The following data is part of a premarket notification filed by Intercare Diagnostics, Inc. with the FDA for The Mirage System Biofeedback Interface.
| Device ID | K941938 |
| 510k Number | K941938 |
| Device Name: | THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE |
| Classification | Device, Biofeedback |
| Applicant | INTERCARE DIAGNOSTICS, INC. 1601 CENTINELA AVE. SUITE 5 Inglewood, CA 90302 |
| Contact | Anthony Dike |
| Correspondent | Anthony Dike INTERCARE DIAGNOSTICS, INC. 1601 CENTINELA AVE. SUITE 5 Inglewood, CA 90302 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-21 |
| Decision Date | 1994-08-05 |