nfant® SSB Sensor 1
nfant® SSB Sensor 1 (NS1) is a Class II device made by NFANT LABS Inc, cleared under FDA 510(k) K143507 on 9 Sep 2015 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00861410000215), 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 | Number00861410000215 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK143507 | Date9 Sep 2015 | StatusActive |
Official records
- AccessGUDID record 00861410000215
- FDA 510(k) database K143507
Across registries
- FDA 510(k) K143507 decided 9 Sep 2015 Active
- FDA GUDID UDI-DI 00861410000215 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K143507
- Listed FDA GUDID 00861410000215
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- nfant® SSB Sensor
- Generic name
- Biofeedback system
- Model / Ref / Catalog
- 1, NS1
- Primary DI / UDI-DI
- 00861410000215
- 510(k) Number
- FDA product code
- HCC
- GMDN term
- Biofeedback system
- Device class
- Class II
- Regulation number
- 882.5050
- GUDID distribution status
- In Commercial Distribution
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