The following data is part of a premarket notification filed by Davicon, Inc. with the FDA for Biofeedback System/3.
| Device ID | K914920 |
| 510k Number | K914920 |
| Device Name: | BIOFEEDBACK SYSTEM/3 |
| Classification | Device, Biofeedback |
| Applicant | DAVICON, INC. C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Contact | Lynne Aronson |
| Correspondent | Lynne Aronson DAVICON, INC. C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-04 |
| Decision Date | 1992-11-16 |