Actiheart AH4
Actiheart AH4 (08-305) is a Class II device made by Camntech Limited, cleared under FDA 510(k) K052489 on 27 Sep 2005 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI B329AH420), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | NumberB329AH420 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK052489 | Date27 Sep 2005 | StatusActive |
Official records
- FDA 510(k) database K052489
Across registries
- FDA 510(k) K052489 decided 27 Sep 2005 Active
- FDA GUDID UDI-DI B329AH420 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K052489
- Listed FDA GUDID B329AH420
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Actiheart
- Generic name
- Telemetric electrocardiographic ambulatory recorder
- Model / Ref / Catalog
- AH4, 08-305
- Primary DI / UDI-DI
- B329AH420
- 510(k) Number
- FDA product code
- GWK
- GMDN term
- Telemetric electrocardiographic ambulatory recorder
- Device class
- Class II
- Regulation number
- 882.1845
- GUDID distribution status
- Not in Commercial Distribution
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