BT8M05S8A
BT8M05S8A is a Class II device made by Koven Technology, Inc., cleared under FDA 510(k) K934638 on 13 May 1994 and listed in FDA GUDID since 9 Mar 2016 (UDI-DI 00894912002357), 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 | Number00894912002357 | Date9 Mar 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK934638 | Date13 May 1994 | StatusActive |
Official records
- AccessGUDID record 00894912002357
- FDA 510(k) database K934638
Across registries
- FDA 510(k) K934638 decided 13 May 1994 Active
- FDA GUDID UDI-DI 00894912002357 listed 9 Mar 2016 Listed
Timeline
- Cleared FDA 510(k) K934638
- Listed FDA GUDID 00894912002357
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Noninvasive vascular ultrasound system probe
- Model / Ref / Catalog
- BT8M05S8A
- Primary DI / UDI-DI
- 00894912002357
- FDA product code
- JOP
- GMDN term
- Noninvasive vascular ultrasound system probe
- Device class
- Class II
- Regulation number
- 870.2880
- GUDID distribution status
- In Commercial Distribution
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