CardioSTAT 10-006
CardioSTAT 10-006 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 18 Dec 2024 (UDI-DI 27540279250029), 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 | Number27540279250029 | Date18 Dec 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK223049 | Date22 Mar 2023 | StatusActive |
Official records
- AccessGUDID record 27540279250029
- FDA 510(k) database K223049
Across registries
- FDA 510(k) K223049 decided 22 Mar 2023 Active
- FDA GUDID UDI-DI 27540279250029 listed 18 Dec 2024 Listed
Timeline
- Cleared FDA 510(k) K223049
- Listed FDA GUDID 27540279250029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CardioSTAT
- Generic name
- Electrocardiographic ambulatory recorder
- Model / reference
- 10-006
- Primary DI / UDI-DI
- 27540279250029
- 510(k) Number
- FDA product code
- DSH, DQK
- GMDN term
- Electrocardiographic ambulatory recorder
- Device class
- Class II
- Regulation number
- 870.2800, 870.1425
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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