The following data is part of a premarket notification filed by Bio-research Associates, Inc. with the FDA for Biopak Measurement System.
| Device ID | K981563 |
| 510k Number | K981563 |
| Device Name: | BIOPAK MEASUREMENT SYSTEM |
| Classification | Device, Muscle Monitoring |
| Applicant | BIO-RESEARCH ASSOCIATES, INC. 4113 NORTH PORT WASHINGTON RD. Milwaukee, WI 53212 |
| Product Code | KZM |
| Subsequent Product Code | NFQ |
| Subsequent Product Code | NFS |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-01 |
| Decision Date | 1998-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003499948 | K981563 | 000 |