K233864 is an FDA 510(k) clearance for the ASSURE Wearable ECG. This device is classified as a Electrocardiograph, Ambulatory (without Analysis) (Class II - Special Controls, product code MWJ).
Submitted by Kestra Medical Technologies, Inc. (Kirkland, US). The FDA issued a Cleared decision on May 7, 2024, 153 days after receiving the submission on December 6, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K233864 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2023 |
| Decision Date | May 07, 2024 |
| Days to Decision | 153 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 |