K232974 is an FDA 510(k) clearance for the EKGenius Smart System. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Ekgenius, LLC (Hempstead, US). The FDA issued a Cleared decision on November 17, 2023, 57 days after receiving the submission on September 21, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K232974 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2023 |
| Decision Date | November 17, 2023 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DPS - Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |