QT ECG
The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity. The model is for EMS (Emergency medical services).
6manufacturers in China registered for this device type
7catalogue numbers in this listing
3510(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 | QT Medical, Inc, United States |
|---|---|
| FDA product code | DXH |
| Device type | Transmitters And Receivers, Electrocardiograph, Telephone |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2920 |
| Establishment | Repacker / relabeller, Complaint-file establishment |
| 510(k) | K180157 |
| Record published | 2019-12-31 |
| Record revised | 2023-04-21 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 93 % RH; Storage environment temperature -25 to 70 °C |
| Packaging | Carrying case box, pack of 50, 50 pcs package of 50, aircraft, pack of 80 |
| Sizes | Depth 72 mm; width 68.02 mm; height 18.6 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| QTERD100 | Depth 72 mm | In distribution |
| QTERD100 | In distribution | |
| QTERD100 | Height 18.6 mm | In distribution |
| QTERD100 | Height 18.6 mm | In distribution |
| QTERD100 | In distribution | |
| QTERD100 | In distribution | |
| QTERD100 | 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 |
| 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 |
| CAM | GE Medical Systems Information Technologies, Inc. | 2 |
Showing 12 of 66. All products under Transmitters And Receivers, Electrocardiograph, Telephone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233521 | 2023-12-06 |
| K220795 | 2022-09-26 |
| K180157 | 2018-05-04 |
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.