Filac 52-0009-00
Filac 52-0009-00 is a Class II device made by SunTech Medical, Inc, cleared under FDA 510(k) K160439 on 6 Jul 2016 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 10840935106579), 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 | Number10840935106579 | Date12 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160439 | Date6 Jul 2016 | StatusActive |
Official records
- AccessGUDID record 10840935106579
- FDA 510(k) database K160439
Across registries
- FDA 510(k) K160439 decided 6 Jul 2016 Active
- FDA GUDID UDI-DI 10840935106579 listed 12 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K160439
- Listed FDA GUDID 10840935106579
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Filac
- Generic name
- Multiple physiological parameter spot-check system, clinical
- Model / reference
- 52-0009-00
- Primary DI / UDI-DI
- 10840935106579
- 510(k) Number
- FDA product code
- DXN
- GMDN term
- Multiple physiological parameter spot-check system, clinical
- Device class
- Class II
- Regulation number
- 870.1130
- GUDID distribution status
- In Commercial Distribution