MAC
MAC 5500 HD Reman
6manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (2), Liaoning (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Ryder Electronics (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Shandong Corecare Technology Limited | Jinan | Shandong | Manufacturer | 2 |
Record
| Listed by | GE Medical Systems Information Technologies, Inc., United States |
|---|---|
| FDA product code | DXH |
| Device type | Transmitters And Receivers, Electrocardiograph, Telephone |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2920 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K110266 |
| Record published | 2017-04-11 |
| Record revised | 2025-04-11 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 15 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -40 to 70 °C |
| Distribution end date | 2024-12-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5500 HD REMAN | In distribution | |
| 5 A4 | In distribution | |
| 5 LITE | In distribution | |
| 3500 | In distribution | |
| 2000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Transmitters And Receivers, Electrocardiograph, Telephone | Proteus Digital Health, Inc. | 10 |
| Sentinel | Spacelabs Healthcare (Washington), Inc | 9 |
| QT ECG | QT Medical, Inc | 7 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 7 |
| LifeWatch Mobile Cardiac Telemetry 3-Lead | Lifewatch Technologies, Ltd. | 6 |
| FibriCheck | Qompium NV | 4 |
| Paceart® System GET Connected III | Medtronic, Inc. | 3 |
| Faros | Bittium Biosignals Ltd. | 3 |
| ECG | Vitalograph Ireland Ltd. | 3 |
| Bioflux | Biotricity | 2 |
| Paceart Optima™ System | Medtronic, Inc. | 2 |
| CAM | GE Medical Systems Information Technologies, Inc. | 2 |
Showing 12 of 66. All products under Transmitters And Receivers, Electrocardiograph, Telephone
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| GE Medical Systems (China) Co., Ltd. | 510(k) number | 2026-04-21 | Class II | Software Manufacturing/Software Deployment | Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making. | 16 |
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.