Kardia Mobile AC-009
by AliveCor
Kardia Mobile AC-009 is a Class II device made by AliveCor, cleared under FDA 510(k) K142672 on 3 Dec 2014 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI B210AC0090), active as of 23 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 | NumberB210AC0090 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142672 | Date3 Dec 2014 | StatusActive |
Official records
- FDA 510(k) database K142672
Across registries
- FDA 510(k) K142672 decided 3 Dec 2014 Active
- FDA GUDID UDI-DI B210AC0090 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K142672
- Listed FDA GUDID B210AC0090
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kardia Mobile
- Generic name
- Electrocardiograph, home-use
- Model / reference
- AC-009
- Primary DI / UDI-DI
- B210AC0090
- FDA product code
- DXH, DPS, QDA
- GMDN term
- Electrocardiograph, home-use
- Device class
- Class II
- Regulation number
- 870.2920, 870.2340, 870.2345
- GUDID distribution status
- In Commercial Distribution
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