Vave VA-0116, VP3
Vave VA-0116, VP3 is a Class II device made by Vave Health Inc, cleared under FDA 510(k) K191541 on 10 Jul 2019 and listed in FDA GUDID since 14 Jun 2021 (UDI-DI 00850001977005), 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 | Number00850001977005 | Date14 Jun 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191541 | Date10 Jul 2019 | StatusActive |
Official records
- AccessGUDID record 00850001977005
- FDA 510(k) database K191541
Across registries
- FDA 510(k) K191541 decided 10 Jul 2019 Active
- FDA GUDID UDI-DI 00850001977005 listed 14 Jun 2021 Listed
Timeline
- Cleared FDA 510(k) K191541
- Listed FDA GUDID 00850001977005
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vave
- Generic name
- Hand-held ultrasound imaging system, body-surface
- Model / reference
- VA-0116, VP3
- Primary DI / UDI-DI
- 00850001977005
- 510(k) Number
- FDA product code
- ITX, IYO, IYN
- GMDN term
- Hand-held ultrasound imaging system, body-surface
- Device class
- Class II
- Regulation number
- 892.1570, 892.1560, 892.1550
- GUDID distribution status
- In Commercial Distribution
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