The following data is part of a premarket notification filed by Bio-feedback Systems, Inc. with the FDA for Miniature Temperature Trainer Model Dt-002.
| Device ID | K905373 |
| 510k Number | K905373 |
| Device Name: | MINIATURE TEMPERATURE TRAINER MODEL DT-002 |
| Classification | Device, Biofeedback |
| Applicant | BIO-FEEDBACK SYSTEMS, INC. 2736 47TH ST. Boulder, CO 80301 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-29 |
| Decision Date | 1991-04-10 |