Comen C80
by Shenzhen Comen Medical Instruments Co., Ltd. 2 variants
Comen C80 is a Class II device made by Shenzhen Comen Medical Instruments Co., Ltd., cleared under FDA 510(k) K112877 on 7 Nov 2012 and listed in FDA GUDID since 11 May 2019 (UDI-DI 06945429082548), active as of 22 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 | Number06945429082548 | Date11 May 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112877 | Date7 Nov 2012 | StatusActive |
Official records
- AccessGUDID record 06945429082548
- FDA 510(k) database K112877
Across registries
- FDA 510(k) K112877 decided 7 Nov 2012 Active
- FDA GUDID UDI-DI 06945429082548 listed 11 May 2019 Listed
Timeline
- Cleared FDA 510(k) K112877
- Listed FDA GUDID 06945429082548
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Comen
- Generic name
- Multiple vital physiological parameter monitoring system, clinical
- Model / reference
- C80
- Primary DI / UDI-DI
- 06945429082548
- 510(k) Number
- FDA product code
- DQA, DPS, DXN, FLL, MWI
- GMDN term
- Multiple vital physiological parameter monitoring system, clinical
- Device class
- Class II
- Regulation number
- 870.2700, 870.2340, 870.1130, 880.2910, 870.2300
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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