K812179 is an FDA 510(k) clearance for the LIFE-TECH #1753 BIOFEEDBACK TRAINER. This device is classified as a Device, Biofeedback (Class II - Special Controls, product code HCC).
Submitted by Life-Tech Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on August 25, 1981, 22 days after receiving the submission on August 3, 1981.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5050.
| 510(k) Number | K812179 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1981 |
| Decision Date | August 25, 1981 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | HCC — Device, Biofeedback |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5050 |