Cardiostation Premier Stand Alone Software
Cardiostation Software sold with wireless devices.
6manufacturers in China registered for this device type
1catalogue number
8510(k) clearances naming this product code
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 | Universal Corporation Limited, India |
|---|---|
| FDA product code | DXH |
| Device type | Transmitters And Receivers, Electrocardiograph, Telephone |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2920 |
| Establishment | Repacker / relabeller |
| Record published | 2017-02-12 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Cardiostation Standalone Software | In distribution |
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 |
| MAC | GE Medical Systems Information Technologies, Inc. | 5 |
| 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 |
Showing 12 of 66. All products under Transmitters And Receivers, Electrocardiograph, Telephone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K083535 | 2008-12-15 |
| K071130 | 2008-05-14 |
| K033451 | 2004-02-05 |
| K980624 | 1998-05-11 |
| K960499 | 1996-08-06 |
| K954495 | 1996-04-22 |
| K943124 | 1995-05-03 |
| K943123 | 1995-05-03 |
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.