K903497 is an FDA 510(k) clearance for the FLEXCOMP DSP & PROCOMP. This device is classified as a Device, Biofeedback (Class II - Special Controls, product code HCC).
Submitted by Thought Technology , Ltd. (Montreal, Quebec, CA). The FDA issued a Cleared decision on February 12, 1991, 193 days after receiving the submission on August 3, 1990.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5050.
| 510(k) Number | K903497 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1990 |
| Decision Date | February 12, 1991 |
| Days to Decision | 193 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 |