Finapres NOVA Frontend Unit
by Finapres Medical Systems B.V.
Finapres NOVA Frontend Unit (FP_910801) is a Class II device made by Finapres Medical Systems B.V., cleared under FDA 510(k) K160967 on 18 Apr 2017 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 08719327003671), 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 | FDA 510(k)SESE | NumberK160967 | Date18 Apr 2017 | StatusActive |
| United States | GUDID listing | Number08719327003671 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 08719327003671
- FDA 510(k) database K160967
- FDA 510(k) database K141460
Across registries
- FDA 510(k) K160967 decided 18 Apr 2017 Active
- FDA GUDID UDI-DI 08719327003671 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K141460
- Listed FDA GUDID 08719327003671
- Cleared FDA 510(k) K160967
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Finapres
- Generic name
- Patient monitoring system module, blood pressure, noninvasive
- Model / Ref / Catalog
- Finapres NOVA Frontend Unit, FP_910801
- Primary DI / UDI-DI
- 08719327003671
- FDA product code
- DXN, DSB
- GMDN term
- Patient monitoring system module, blood pressure, noninvasive
- Device class
- Class II
- Regulation number
- 870.1130, 870.2770
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Patient monitoring system module, blood pressure, noninvasive.