Nonin 7600
by Nonin Medical, Inc. 3 variants
Nonin 7600 is a Class II device made by Nonin Medical, Inc., cleared under FDA 510(k) K090807 on 30 Jun 2009 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00849686074123), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00849686074123 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK090807 | Date30 Jun 2009 | StatusActive |
Official records
- AccessGUDID record 00849686074123
- FDA 510(k) database K090807
Across registries
- FDA 510(k) K090807 decided 30 Jun 2009 Active
- FDA GUDID UDI-DI 00849686074123 listed 22 Sep 2016 Listed
Recalls
-
- Terminated Z-0458-2010
A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the POD. This overheating, while unlikely to occur, has the potential to cause a burn if the POD is in direct contact with the patient.
Timeline
- Cleared FDA 510(k) K090807
- Recall initiated FDA recalls Z-0458-2010
- Listed FDA GUDID 00849686074123
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Nonin
- Generic name
- Cerebral oximeter
- Model / reference
- 7600
- Primary DI / UDI-DI
- 00849686074123
- 510(k) Number
- 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