VitalScan HRV HW6
by Medeia Inc
VitalScan HRV HW6 is a Class II device made by Medeia Inc, cleared under FDA 510(k) K083735 on 18 Feb 2009 and listed in FDA GUDID since 5 Feb 2025 (UDI-DI 08690020003031), 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 | Number08690020003031 | Date5 Feb 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK083735 | Date18 Feb 2009 | StatusActive |
Official records
- AccessGUDID record 08690020003031
- FDA 510(k) database K083735
Across registries
- FDA 510(k) K083735 decided 18 Feb 2009 Active
- FDA GUDID UDI-DI 08690020003031 listed 5 Feb 2025 Listed
Timeline
- Cleared FDA 510(k) K083735
- Listed FDA GUDID 08690020003031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VitalScan HRV
- Generic name
- Pulse Co-oximeter probe, reusable
- Model / reference
- HW6
- Primary DI / UDI-DI
- 08690020003031
- 510(k) Number
- FDA product code
- DPS, JOM
- GMDN term
- Pulse Co-oximeter probe, reusable
- Device class
- Class II
- Regulation number
- 870.2340, 870.2780
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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