The following data is part of a premarket notification filed by Bio-feedback Systems, Inc. with the FDA for Feedback Emg System Pe-020.
| Device ID | K832333 |
| 510k Number | K832333 |
| Device Name: | FEEDBACK EMG SYSTEM PE-020 |
| Classification | Device, Biofeedback |
| Applicant | BIO-FEEDBACK SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-18 |
| Decision Date | 1983-09-01 |