Monitor, Physiological, Patient(With Arrhythmia Detection or Alarms)
Interface for BSM-6501A/K and BSM-6701A/K (1 Multi-link socket, 1 RS-232C socket, 1 Alarm socket, 1 RGB socket)
9manufacturers in China registered for this device type
205catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| General Meditech, Inc. | Shenzhen | Guangdong | Complaint-file establishment | 3 |
Record
| Listed by | Nihon Kohden Corp., Japan |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K945578 |
| Record published | 2021-09-27 |
| Record revised | 2024-04-15 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| YS-118P3 | In distribution | ||
| JT-950P | In distribution | ||
| WS-671P | In distribution | ||
| TG-900P | In distribution | ||
| QI-671P | In distribution | ||
| BR-913PA | In distribution | ||
| ZM-920PA | In distribution | ||
| YS-096P5 | In distribution | ||
| JA-694PA | In distribution | ||
| IF-937P | In distribution | ||
| PU-681RA | In distribution | ||
| WS-960P | In distribution | ||
| QF-911P | In distribution | ||
| YS-106P6 | In distribution | ||
| JL-500P1 | In distribution | ||
| WEP-4208A | In distribution | ||
| SC-170R | In distribution | ||
| YP-715T | In distribution | ||
| IF-919P | In distribution | ||
| QI-372P | In distribution | ||
| YP-713T | Adult | In distribution | |
| JL-631P | In distribution | ||
| YJ-910P | In distribution | ||
| YS-096P3 | In distribution | ||
| YS-119P1 | In distribution | ||
| YS-096P2 | In distribution | ||
| YS-106P7 | In distribution | ||
| YS-107P4 | In distribution | ||
| IF-923P | In distribution | ||
| YS-097P8 | In distribution | ||
| QI-170P | In distribution | ||
| YS-105P6 | In distribution | ||
| IF-956P | In distribution | ||
| DH-156P | In distribution | ||
| IF-912P | In distribution | ||
| IF-914P | In distribution | ||
| JL-930P | In distribution | ||
| YS-094P2 | In distribution | ||
| PU-621R | In distribution | ||
| YS-116P6 | In distribution | ||
| DH-159P | In distribution | ||
| YP-714T | Adult, Large | In distribution | |
| YL-611P | In distribution | ||
| SC-611R | In distribution | ||
| YJ-671P | In distribution | ||
| YS-107P3 | In distribution | ||
| IF-950P | In distribution | ||
| IF-954P | In distribution | ||
| DH-155P | In distribution | ||
| WS-371P | In distribution | ||
| QF-909P | In distribution | ||
| AY-671P | In distribution | ||
| IF-19004 | In distribution | ||
| ZM-921PA | In distribution | ||
| IF-955P | In distribution | ||
| QI-632P | In distribution | ||
| YS-107P2 | In distribution | ||
| YS-095P6 | In distribution | ||
| YS-105P5 | In distribution | ||
| IF-963P | In distribution | ||
| SB-671P | In distribution | ||
| YS-108P0 | In distribution | ||
| JP-900P | In distribution | ||
| YS-116P1 | In distribution | ||
| YS-106P3 | In distribution | ||
| DH-350P | In distribution | ||
| YS-116P7 | In distribution | ||
| QI-420PA | In distribution | ||
| YS-118P0 | In distribution | ||
| YS-108P2 | In distribution | ||
| JL-630P | In distribution | ||
| QI-631P | In distribution | ||
| BJ-900PA | In distribution | ||
| YP-811P | 20 | In distribution | |
| IF-930P | In distribution | ||
| YS-116P4 | In distribution | ||
| YS-105P7 | In distribution | ||
| IF-939P | In distribution | ||
| DH-157P | In distribution | ||
| YS-113P8 | In distribution | ||
| IF-920P | In distribution | ||
| IF-952P | In distribution | ||
| ZS-910PA | In distribution | ||
| IF-944P | In distribution | ||
| YP-712T | Child | In distribution | |
| IF-928P | In distribution | ||
| IF-961P | In distribution | ||
| AA-674P | In distribution | ||
| AY-631P | In distribution | ||
| QI-600P | In distribution | ||
| IF-925P | In distribution | ||
| YS-097P9 | In distribution | ||
| DZ-170P | In distribution | ||
| YJ-672P | In distribution | ||
| JT-900P | In distribution | ||
| IF-946P | In distribution | ||
| YJ-920P | In distribution | ||
| YS-104P5 | In distribution | ||
| YS-118P8 | In distribution | ||
| IF-913P | In distribution | ||
| IF-948P | In distribution | ||
| IF-958P | In distribution | ||
| DH-220P | In distribution | ||
| YS-119P4 | In distribution | ||
| TG-101T | In distribution | ||
| YN-921P | Neonatal | In distribution | |
| YS-097P5 | In distribution | ||
| QF-903P | In distribution | ||
| QF-902P | In distribution | ||
| YP-710T | Infant | In distribution | |
| QF-907P | In distribution | ||
| YP-711T | Child, Small | In distribution | |
| YP-815P | 20 | In distribution | |
| AY-633P | In distribution | ||
| YS-097P6 | In distribution | ||
| YS-106P8 | In distribution | ||
| YS-108P1 | In distribution | ||
| YN-990P | In distribution | ||
| YG-101T | 50 | In distribution | |
| DH-150P | In distribution | ||
| YS-116P2 | In distribution | ||
| DH-154P | In distribution | ||
| IF-951P | In distribution | ||
| YN-901P | Adult | In distribution | |
| YS-107P9 | In distribution | ||
| YG-214T | Neonatal | 30 | In distribution |
| YS-116P3 | In distribution | ||
| IF-932P | In distribution | ||
| QI-373P | In distribution | ||
| DH-170P | In distribution | ||
| DH-190P | In distribution | ||
| QF-801P | In distribution | ||
| YS-113P9 | In distribution | ||
| IF-917P | In distribution | ||
| BR-943PA | In distribution | ||
| IF-927P | In distribution | ||
| DH-152P | In distribution | ||
| YS-19003 | In distribution | ||
| IF-942P | In distribution | ||
| JC-906PA | In distribution | ||
| SB-920P | In distribution | ||
| AY-673P | In distribution | ||
| IF-922P | In distribution | ||
| RY-910PA | In distribution | ||
| TL-051S | 5 | In distribution | |
| QI-430PA | In distribution | ||
| JL-639P | In distribution | ||
| YS-116P5 | In distribution | ||
| YN-980S | In distribution | ||
| YS-63015 | In distribution | ||
| QI-672P | In distribution | ||
| QI-634P | In distribution | ||
| YP-817P | 20 | In distribution | |
| JA-690PA | In distribution | ||
| YS-112P4 | In distribution | ||
| YN-925P | In distribution | ||
| JL-650P | In distribution | ||
| YN-924P | In distribution | ||
| JA-920P | In distribution | ||
| MU-971RA | In distribution | ||
| BR-936PA | In distribution | ||
| AY-651P | In distribution | ||
| IF-916P | In distribution | ||
| YS-118P2 | In distribution | ||
| DH-158P | In distribution | ||
| IF-943P | In distribution | ||
| YS-106P4 | In distribution | ||
| YS-098P1 | In distribution | ||
| YS-116P0 | In distribution | ||
| JL-632P | In distribution | ||
| JP-920P | In distribution | ||
| QF-921P | In distribution | ||
| YP-816P | 20 | In distribution | |
| DM-190P | In distribution | ||
| YN-920P | Neonatal | In distribution | |
| QF-908P | In distribution | ||
| YS-105P8 | In distribution | ||
| YS-106P9 | In distribution | ||
| DH-151P | In distribution | ||
| YS-106P5 | In distribution | ||
| IF-957P | In distribution | ||
| QF-901P | In distribution | ||
| YS-119P3 | In distribution | ||
| YS-105P0 | In distribution | ||
| IF-935P | In distribution | ||
| JP-910P | In distribution | ||
| AY-653P | In distribution | ||
| YL-920P | In distribution | ||
| BR-946PA | In distribution | ||
| YS-119P2 | In distribution | ||
| YN-981S | In distribution | ||
| JG-900P | In distribution | ||
| YS-098P2 | In distribution | ||
| YP-840T | 20 | In distribution | |
| YS-118P1 | In distribution | ||
| YL-612P | In distribution | ||
| AA-174P | In distribution | ||
| YS-116P8 | In distribution | ||
| DM-191P | In distribution | ||
| JL-030U2 | In distribution | ||
| YS-118P9 | In distribution | ||
| YS-107P1 | In distribution | ||
| SB-170P | In distribution | ||
| YN-900P | Adult | In distribution | |
| DH-153P | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 326 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 266 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden America, Inc. | 139 |
| Surveyor Central | Mortara Instrument, Inc. | 71 |
| Tempus Pro | Remote Diagnostic Technologies Ltd. | 44 |
| Surveyor S12 | Mortara Instrument, Inc. | 38 |
| Ultraview | Spacelabs Healthcare (Washington), Inc | 29 |
| Surveyor S19 | Mortara Instrument, Inc. | 26 |
| Vital Signs™ | AirLife Finland Oy | 23 |
| Patient Monitor | Edan Instruments, Inc. | 22 |
| Telemetry Accessories | Philips Medizin Systeme Böblingen GmbH | 21 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 20 |
Showing 12 of 589. All products under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203435 | 2021-07-16 |
| K163459 | 2017-04-04 |
| K153707 | 2016-09-02 |
| K151080 | 2015-11-05 |
| K112637 | 2011-12-09 |
| K102376 | 2010-12-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.