CloudEKG
The CloudEKG device is a 12 standard leads battery operated unit intended for recording and transmitting standard electrocardiogram signals for cardiac monitoring and diagnosis by…
The CloudEKG device is a 12 standard leads battery operated unit intended for recording and transmitting standard electrocardiogram signals for cardiac monitoring and diagnosis by healthcare professionals. Recorded signals are processed by the device and transmitted to a PC or hand-held monitoring device wirelessly using Bluetooth technology. The transmitted signals are displayed on the monitoring device to allow for their review, analysis, saving and printing by healthcare professionals. CloudEKG can be ‘used in adults and infants weighing less than 22 lbs (10 Kg) but is not appropriate for use to monitor critical patients or perform intracardiac recordings. All measurements obtained with the CloudEKG device should take into account the patient’s clinical symptoms and findings to be considered valid and no treatment by drugs or other therapies should be initiated based solely on the measurements obtained with the device.
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 | Neurosoft, OOO |
|---|---|
| FDA product code | DXH |
| Device type | Transmitters And Receivers, Electrocardiograph, Telephone |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2920 |
| 510(k) | K130878 |
| Record published | 2016-09-21 |
| Record revised | 2023-06-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CloudEKG | 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
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.