K250356 is an FDA 510(k) clearance for the MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000). This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Infobionic, Inc. (Chelmsford, US). The FDA issued a Cleared decision on July 29, 2025, 172 days after receiving the submission on February 7, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K250356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2025 |
| Decision Date | July 29, 2025 |
| Days to Decision | 172 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 |