K241217 is an FDA 510(k) clearance for the CloudHRV™ System (100-01-001). This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Inmedix, Inc. (Normandy Park, US). The FDA issued a Cleared decision on January 16, 2025, 260 days after receiving the submission on May 1, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K241217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2024 |
| Decision Date | January 16, 2025 |
| Days to Decision | 260 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 |