K243566 is an FDA 510(k) clearance for the CardioTag™. This device is classified as a Ballistocardiograph (Class II - Special Controls, product code DXR).
Submitted by Cardiosense, Inc. (Chicago, US). The FDA issued a Cleared decision on July 22, 2025, 246 days after receiving the submission on November 18, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2320.
| 510(k) Number | K243566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2024 |
| Decision Date | July 22, 2025 |
| Days to Decision | 246 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXR - Ballistocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2320 |