Telemetry Accessories
ECG 5L Grabber, AAMI, Masimo SpO2 , Tele
9manufacturers in China registered for this device type
21catalogue numbers in this listing
5510(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 | Philips Medizin Systeme Böblingen GmbH, Germany |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Record published | 2026-05-26 |
| Record revised | 2026-07-21 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Storage environment temperature -40 to 60 °C; Storage environment temperature -40 to 140 °F; Storage environment humidity 15 to 90 % RH; Storage environment atmospheric pressure 10 to 108 KiloPascal |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ECG 5 lead Grabber, IEC, Tele | In distribution | |
| ECG 6 lead Grabber, IEC + SpO2, Tele | In distribution | |
| Telemetry Adapter 5L+SpO2 | In distribution | |
| ECG 6 lead Grabber, AAMI + SpO2, Tele | In distribution | |
| ECG 6 lead Grabber, AAMI, Tele | In distribution | |
| ECG 6 lead Grabber, IEC, Tele | In distribution | |
| Telemetry Adapter 6-Lead + Masimo SpO2 | In distribution | |
| Telemetry Adapter 3L+SpO2 | In distribution | |
| ECG 5 lead Grabber, AAMI + SpO2, Tele | In distribution | |
| Telemetry Adapter 5-Lead + Masimo SpO2 | In distribution | |
| ECG 3 lead Grabber, AAMI + SpO2, Tele | In distribution | |
| ECG 5L Grabber, AAMI, Masimo SpO2 , Tele | In distribution | |
| Telemetry Adapter SpO2-only | In distribution | |
| ECG 5 lead Grabber, AAMI, Tele | In distribution | |
| Telemetry Adapter Masimo SpO2-only | In distribution | |
| Telemetry Adapter 6L+SpO2 | In distribution | |
| ECG 5 lead Snaps, AAMI + SpO2, Tele | In distribution | |
| ECG 5 lead Snaps, AAMI, Tele | In distribution | |
| ECG 5L Grabber, IEC, Masimo SpO2 , Tele | In distribution | |
| ECG 3 lead Grabber, IEC + SpO2, Tele | In distribution | |
| ECG 5 lead Grabber, IEC + SpO2, Tele | 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 Corp. | 205 |
| 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 |
| 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 |
|---|---|
| K251702 | 2025-11-10 |
| K250453 | 2025-09-02 |
| K242962 | 2025-05-05 |
| K221348 | 2023-02-03 |
| K211900 | 2022-03-04 |
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.