K011983 is an FDA 510(k) clearance for the INSIGHT GENESIS. This device is classified as a Device, Biofeedback (Class II - Special Controls, product code HCC).
Submitted by Fasstech (Burlington, US). The FDA issued a Cleared decision on August 30, 2001, 65 days after receiving the submission on June 26, 2001.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5050.
| 510(k) Number | K011983 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2001 |
| Decision Date | August 30, 2001 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCC — Device, Biofeedback |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5050 |