The following data is part of a premarket notification filed by Bio-research Associates, Inc. with the FDA for Bioemg Ii And Biojva.
| Device ID | K003176 |
| 510k Number | K003176 |
| Device Name: | BIOEMG II AND BIOJVA |
| Classification | Device, Muscle Monitoring |
| Applicant | BIO-RESEARCH ASSOCIATES, INC. 4113 NORTH PORT WASHINGTON RD. Milwaukee, WI 53212 |
| Contact | John C Radke |
| Correspondent | John C Radke BIO-RESEARCH ASSOCIATES, INC. 4113 NORTH PORT WASHINGTON RD. Milwaukee, WI 53212 |
| Product Code | KZM |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-11 |
| Decision Date | 2001-01-04 |