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Ldwr SET,SNAP,DIN,ECG,61CM/24IN,AAMI,3LW/ST,1/ST
9manufacturers in China registered for this device type
19catalogue numbers in this listing
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 | Spacelabs Healthcare (Washington), Inc |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| 510(k) | K983996 |
| Record published | 2017-03-07 |
| Record revised | 2025-07-22 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment humidity 0 to 0 % RH; Storage environment temperature 0 to 0 °C |
| Distribution end date | 2025-05-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ECG Cables & Leadwires | 61 cm/24″ length | In distribution |
| ECG Cables & Leadwires | 61 cm/ 24″ Length | In distribution |
| ECG Cables & Leadwires | 61 cm/ 24″ Length | In distribution |
| ECG Cables & Leadwires | 61 cm/ 24″ Length | In distribution |
| ECG Cables & Leadwires | 61 cm/24″ Length | In distribution |
| ECG Cables & Leadwires | 61 cm/ 24″ Length | In distribution |
| ECG Cables & Leadwires | 61 cm/ 24″ Length | In distribution |
| ECG Cables & Leadwires | 61 cm/ 24″ Length | In distribution |
| ECG Cables & Leadwires | 64 cm/25.2in Length | In distribution |
| ECG Cables & Leadwires | 61 cm/ 24″ Length | In distribution |
| 90347 | In distribution | |
| ECG Cables & Leadwires | 61 cm/ 24″ Length | Withdrawn |
| 90600 | Withdrawn | |
| ECG Cables & Leadwires | 61 cm/ 24″ Length | Withdrawn |
| 015-0133-01 | Withdrawn | |
| ECG Cables & Leadwires | 61 cm/ 24″ Length | Withdrawn |
| 90347 | Withdrawn | |
| 90347 | Withdrawn | |
| ECG Cables & Leadwires | 61 cm /24″ Length | Withdrawn |
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 |
| Telemetry Accessories | Philips Medizin Systeme Böblingen GmbH | 21 |
Showing 12 of 589. All products under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Spacelabs Healthcare Ltd. | 510(k) number | 2014-07-02 | Class II | Software design | The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of recall Z-0871-2014 because additional s | 8 units | 2014-10-16 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2013-12-19 | Class II | Software design | The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (transmitter) display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sens | 1057 units (988 in the US and 69 outside of the US). | 2014-06-12 |
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.