COSMED K4b2
COSMED K4b2 is a Class II device made by C O S M E D SRL, cleared under FDA 510(k) K963373 on 10 Sep 1997 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 18052400180126), 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 | Number18052400180126 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK963373 | Date10 Sep 1997 | StatusActive |
Official records
- AccessGUDID record 18052400180126
- FDA 510(k) database K963373
Across registries
- FDA 510(k) K963373 decided 10 Sep 1997 Active
- FDA GUDID UDI-DI 18052400180126 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K963373
- Listed FDA GUDID 18052400180126
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cosmed
- Generic name
- Cardiopulmonary stress exercise monitoring system
- Model / reference
- K4b2
- Primary DI / UDI-DI
- 18052400180126
- 510(k) Number
- FDA product code
- BZC
- GMDN term
- Cardiopulmonary stress exercise monitoring system
- Device class
- Class II
- Regulation number
- 868.1880
- GUDID distribution status
- In Commercial Distribution
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