The following data is part of a premarket notification filed by Verimed Holdings, Inc. with the FDA for Biofeedback Device.
| Device ID | K954127 |
| 510k Number | K954127 |
| Device Name: | BIOFEEDBACK DEVICE |
| Classification | Device, Biofeedback |
| Applicant | VERIMED HOLDINGS, INC. 11950 N.W. 39TH ST., SUITE D Coral Springs, FL 33065 |
| Contact | Christopher J Chase |
| Correspondent | Christopher J Chase VERIMED HOLDINGS, INC. 11950 N.W. 39TH ST., SUITE D Coral Springs, FL 33065 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-31 |
| Decision Date | 1995-11-14 |