BreathCO 2900
BreathCO 2900 is a Class II device made by Vitalograph Ireland, Ltd., cleared under FDA 510(k) K892524 on 5 May 1989 and listed in FDA GUDID since 11 Mar 2021 (UDI-DI 15099169297507), 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 | Number15099169297507 | Date11 Mar 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK892524 | Date5 May 1989 | StatusActive |
Official records
- AccessGUDID record 15099169297507
- FDA 510(k) database K892524
Across registries
- FDA 510(k) K892524 decided 5 May 1989 Active
- FDA GUDID UDI-DI 15099169297507 listed 11 Mar 2021 Listed
Timeline
- Cleared FDA 510(k) K892524
- Listed FDA GUDID 15099169297507
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BreathCO
- Generic name
- Carbon monoxide breath analyser
- Model / reference
- 2900
- Primary DI / UDI-DI
- 15099169297507
- 510(k) Number
- FDA product code
- CCJ
- GMDN term
- Carbon monoxide breath analyser
- Device class
- Class II
- Regulation number
- 868.1430
- GUDID distribution status
- In Commercial Distribution
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