The following data is part of a premarket notification filed by Bio-research Associates, Inc. with the FDA for Bioemg Iii.
| Device ID | K082927 |
| 510k Number | K082927 |
| Device Name: | BIOEMG III |
| Classification | Device, Muscle Monitoring |
| Applicant | BIO-RESEARCH ASSOCIATES, INC. 9275 NORTH 49TH STREET SUITE 150 Brown Deer, WI 53223 |
| Contact | John Radke |
| Correspondent | John Radke BIO-RESEARCH ASSOCIATES, INC. 9275 NORTH 49TH STREET SUITE 150 Brown Deer, WI 53223 |
| Product Code | KZM |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-01 |
| Decision Date | 2009-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003499900 | K082927 | 000 |