BioPAK 9
by Bio-Research Associates, Inc.
BioPAK 9 is a jaw physiology evaluation system (FDA Class II; FDA product code KZM, Device, Muscle Monitoring) made by Bio-Research Associates, Inc., cleared under FDA 510(k) K981563 on 15 Sep 1998 and listed in FDA GUDID since 22 Jun 2023 (UDI-DI 00860003499948), 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 | Number00860003499948 | Date22 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK981563 | Date15 Sep 1998 | StatusActive |
Official records
- AccessGUDID record 00860003499948
- FDA 510(k) database K981563
Across registries
- FDA 510(k) K981563 decided 15 Sep 1998 Active
- FDA GUDID UDI-DI 00860003499948 listed 22 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K981563
- Listed FDA GUDID 00860003499948
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BioPAK
- Generic name
- Jaw physiology evaluation system
- Model / reference
- 9
- Primary DI / UDI-DI
- 00860003499948
- 510(k) Number
- FDA product code
- KZM
- GMDN term
- Jaw physiology evaluation system
- Device class
- Class II
- Regulation number
- 890.1375
- GUDID distribution status
- In Commercial Distribution
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