Masimo W1 95137
Masimo W1 95137 is a Class II device made by Masimo Corporation, cleared under FDA 510(k) K232512 on 17 Nov 2023 and listed in FDA GUDID since 1 Mar 2024 (UDI-DI 00843997017978), 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 | Number00843997017978 | Date1 Mar 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK232512 | Date17 Nov 2023 | StatusActive |
Official records
- AccessGUDID record 00843997017978
- FDA 510(k) database K232512
Across registries
- FDA 510(k) K232512 decided 17 Nov 2023 Active
- FDA GUDID UDI-DI 00843997017978 listed 1 Mar 2024 Listed
Timeline
- Cleared FDA 510(k) K232512
- Listed FDA GUDID 00843997017978
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Masimo W1
- Generic name
- Wearable multiple vital physiological parameter monitoring system
- Model / reference
- 95137
- Primary DI / UDI-DI
- 00843997017978
- 510(k) Number
- FDA product code
- DPS
- GMDN term
- Wearable multiple vital physiological parameter monitoring system
- Device class
- Class II
- Regulation number
- 870.2340
- GUDID distribution status
- In Commercial Distribution