Sensoronics SB-MALNC-3P
Sensoronics SB-MALNC-3P is a Class II device made by Sensoronics Incorporated, cleared under FDA 510(k) K083010 on 10 Jun 2009 and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 00851456007187), 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 | Number00851456007187 | Date26 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK083010 | Date10 Jun 2009 | StatusActive |
Official records
- AccessGUDID record 00851456007187
- FDA 510(k) database K083010
Across registries
- FDA 510(k) K083010 decided 10 Jun 2009 Active
- FDA GUDID UDI-DI 00851456007187 listed 26 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K083010
- Listed FDA GUDID 00851456007187
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sensoronics
- Generic name
- Pulse oximeter probe, reusable
- Model / reference
- SB-MALNC-3P
- Primary DI / UDI-DI
- 00851456007187
- 510(k) Number
- FDA product code
- DQA
- GMDN term
- Pulse oximeter probe, reusable
- Device class
- Class II
- Regulation number
- 870.2700
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Pulse oximeter probe, reusable.