CloudEKG
CloudEKG is a Class II device made by Neurosoft, Ooo, cleared under FDA 510(k) K130878 on 4 Apr 2014 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04650075330081), active as of 21 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04650075330081 | Date21 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK130878 | Date4 Apr 2014 | StatusActive |
Official records
- AccessGUDID record 04650075330081
- FDA 510(k) database K130878
Across registries
- FDA 510(k) K130878 decided 4 Apr 2014 Active
- FDA GUDID UDI-DI 04650075330081 listed 21 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K130878
- Listed FDA GUDID 04650075330081
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Electrocardiograph, professional, multichannel
- Model / reference
- CloudEKG
- Primary DI / UDI-DI
- 04650075330081
- 510(k) Number
- FDA product code
- DXH
- GMDN term
- Electrocardiograph, professional, multichannel
- Device class
- Class II
- Regulation number
- 870.2920
- GUDID distribution status
- In Commercial Distribution
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