Masimo Sensor 4935
Masimo Sensor 4935 is a Class II device made by Masimo Corporation, cleared under FDA 510(k) K183697 on 15 May 2019 and listed in FDA GUDID since 8 Oct 2021 (UDI-DI 00843997016797), 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 | Number00843997016797 | Date8 Oct 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK183697 | Date15 May 2019 | StatusActive |
Official records
- AccessGUDID record 00843997016797
- FDA 510(k) database K183697
Across registries
- FDA 510(k) K183697 decided 15 May 2019 Active
- FDA GUDID UDI-DI 00843997016797 listed 8 Oct 2021 Listed
Timeline
- Cleared FDA 510(k) K183697
- Listed FDA GUDID 00843997016797
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Masimo Sensor
- Generic name
- Pulse Co-oximeter
- Model / reference
- 4935
- Description
- Masimo Sensor Replacement
- Primary DI / UDI-DI
- 00843997016797
- 510(k) Number
- FDA product code
- MWI
- GMDN term
- Pulse Co-oximeter
- Device class
- Class II
- Regulation number
- 870.2300
- GUDID distribution status
- In Commercial Distribution