CORTEX CPET System MetaLyzer3B
CORTEX CPET System MetaLyzer3B is a Class II device made by Cortex Biophysik GmbH, cleared under FDA 510(k) K993641 on 14 Dec 2000 and listed in FDA GUDID since 24 Sep 2020 (UDI-DI 74250179233555), 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 | Number74250179233555 | Date24 Sep 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK993641 | Date14 Dec 2000 | StatusActive |
Official records
- AccessGUDID record 74250179233555
- FDA 510(k) database K993641
Across registries
- FDA 510(k) K993641 decided 14 Dec 2000 Active
- FDA GUDID UDI-DI 74250179233555 listed 24 Sep 2020 Listed
Timeline
- Cleared FDA 510(k) K993641
- Listed FDA GUDID 74250179233555
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CORTEX CPET System
- Generic name
- Cardiopulmonary stress exercise monitoring system
- Model / reference
- MetaLyzer3B
- Primary DI / UDI-DI
- 74250179233555
- 510(k) Number
- FDA product code
- BTY
- GMDN term
- Cardiopulmonary stress exercise monitoring system
- Device class
- Class II
- Regulation number
- 868.1890
- GUDID distribution status
- In Commercial Distribution
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