K850643 is an FDA 510(k) clearance for the HR/BVP 100T HEART RATE MONITOR. 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 May 17, 1985, 87 days after receiving the submission on February 19, 1985.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5050.
| 510(k) Number | K850643 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 1985 |
| Decision Date | May 17, 1985 |
| Days to Decision | 87 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 |