Invos PM7100
Invos PM7100 is a Class II device made by Covidien LP, cleared under FDA 510(k) K211561 on 5 Dec 2021 (1 earlier submission) and listed in FDA GUDID since 12 Jun 2019 (UDI-DI 10884521780071), active as of 2 Nov 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211561 | Date5 Dec 2021 | StatusActive |
| United States | GUDID listing | Number10884521780071 | Date12 Jun 2019 | StatusListed |
Official records
- AccessGUDID record 10884521780071
- FDA 510(k) database K211561
- FDA 510(k) database K182868
Across registries
- FDA 510(k) K211561 decided 5 Dec 2021 Active
- FDA GUDID UDI-DI 10884521780071 listed 12 Jun 2019 Listed
Recalls
-
- Ongoing Z-1732-2024
- Ongoing Z-1731-2024
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
Timeline
- Cleared FDA 510(k) K182868
- Listed FDA GUDID 10884521780071
- Cleared FDA 510(k) K211561
- Recall initiated FDA recalls Z-1732-2024
- Recall initiated FDA recalls Z-1731-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Invos
- Generic name
- Cerebral oximeter
- Model / reference
- PM7100
- Primary DI / UDI-DI
- 10884521780071
- FDA product code
- MUD
- GMDN term
- Cerebral oximeter
- Device class
- Class II
- Regulation number
- 870.2700
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe