Eart 10-501
by Icentia Inc
Eart 10-501 is a Class II device made by Icentia Inc, cleared under FDA 510(k) K223049 on 22 Mar 2023 and listed in FDA GUDID since 26 Mar 2024 (UDI-DI 17540279105018), active as of 12 Nov 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 | Number17540279105018 | Date26 Mar 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK223049 | Date22 Mar 2023 | StatusActive |
Official records
- AccessGUDID record 17540279105018
- FDA 510(k) database K223049
Across registries
- FDA 510(k) K223049 decided 22 Mar 2023 Active
- FDA GUDID UDI-DI 17540279105018 listed 26 Mar 2024 Listed
Timeline
- Cleared FDA 510(k) K223049
- Listed FDA GUDID 17540279105018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Eart
- Generic name
- Electrocardiographic long-term ambulatory recording analyser application software
- Model / reference
- 10-501
- Primary DI / UDI-DI
- 17540279105018
- 510(k) Number
- FDA product code
- DSH, DQK
- GMDN term
- Electrocardiographic long-term ambulatory recording analyser application software
- Device class
- Class II
- Regulation number
- 870.2800, 870.1425
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Electrocardiographic long-term ambulatory recording analyser application software.