Bioemg III
by Bio-Research Associates, Inc.
510(k) K082927
Bioemg III is a medical device (FDA Class II; FDA product code KZM, Device, Muscle Monitoring) made by Bio-Research Associates, Inc., cleared under FDA 510(k) K082927 on 6 Feb 2009, active as of 9 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082927 | Date6 Feb 2009 | StatusActive |
Official records
- FDA 510(k) database K082927
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KZM
- Device class
- Class II
- Regulation
- 21 CFR Part 890.1375
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K082927
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| BioEMG III NRG V2 | III NRG V2 | 00860003499900 | — | On the market |
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