The following data is part of a premarket notification filed by Bio-feedback Systems, Inc. with the FDA for Feedback Edr System Model Me-1.
| Device ID | K792659 |
| 510k Number | K792659 |
| Device Name: | FEEDBACK EDR SYSTEM MODEL ME-1 |
| Classification | Device, Biofeedback |
| Applicant | BIO-FEEDBACK SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-26 |
| Decision Date | 1980-01-09 |