K200036 is an FDA 510(k) clearance for the AI-ECG Tracker. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Shenzhen Carewell Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 20, 2020, 72 days after receiving the submission on January 8, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K200036 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2020 |
| Decision Date | March 20, 2020 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS - Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |