K211709 is an FDA 510(k) clearance for the Biotres. This device is classified as a Electrocardiograph, Ambulatory (without Analysis) (Class II - Special Controls, product code MWJ).
Submitted by Biotricity (Redwood City, US). The FDA issued a Cleared decision on January 19, 2022, 230 days after receiving the submission on June 3, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K211709 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2021 |
| Decision Date | January 19, 2022 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MWJ - Electrocardiograph, Ambulatory (without Analysis) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |