Cosmed K4
by COSMED Srl
510(k) K963373
Cosmed K4 is a Class II device made by COSMED Srl, cleared under FDA 510(k) K963373 on 10 Sep 1997, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK963373 | Date10 Sep 1997 | StatusActive |
Official records
- FDA 510(k) database K963373
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BZC
- Device class
- Class II
- Regulation
- 21 CFR Part 868.1880
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K963373
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| COSMED K4b2 | K4b2 | 18052400180157 | — | On the market |
| COSMED K4b2 | K4b2 | 18052400180126 | — | On the market |
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