SCHILLER SpO2 sensor Children
SCHILLER SpO2 sensor Children (0-13-0039) is a Class II device made by Schiller Medical, cleared under FDA 510(k) K023195 on 3 Jun 2003 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 07613365900057), 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 | Number07613365900057 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK023195 | Date3 Jun 2003 | StatusActive |
Official records
- AccessGUDID record 07613365900057
- FDA 510(k) database K023195
Across registries
- FDA 510(k) K023195 decided 3 Jun 2003 Active
- FDA GUDID UDI-DI 07613365900057 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K023195
- Listed FDA GUDID 07613365900057
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Schiller
- Generic name
- Pulse oximeter probe, reusable
- Model / Ref / Catalog
- SpO2 sensor Children, 0-13-0039
- Primary DI / UDI-DI
- 07613365900057
- 510(k) Number
- FDA product code
- MWI
- GMDN term
- Pulse oximeter probe, reusable
- Device class
- Class II
- Regulation number
- 870.2300
- GUDID distribution status
- In Commercial Distribution