K231276 is an FDA 510(k) clearance for the SmartCardia 7L Platform. This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Smartcardia SA (Lausanne, CH). The FDA issued a Cleared decision on August 30, 2023, 120 days after receiving the submission on May 2, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K231276 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2023 |
| Decision Date | August 30, 2023 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSI - Detector And Alarm, Arrhythmia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |