K823146 is an FDA 510(k) clearance for the CALMSET 3 TM. This device is classified as a Device, Biofeedback (Class II - Special Controls, product code HCC).
Submitted by Thought Technology , Ltd. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1982, 39 days after receiving the submission on October 25, 1982.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5050.
| 510(k) Number | K823146 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1982 |
| Decision Date | December 03, 1982 |
| Days to Decision | 39 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 |