K230265 is an FDA 510(k) clearance for the MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System. 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 October 6, 2023, 248 days after receiving the submission on January 31, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K230265 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2023 |
| Decision Date | October 06, 2023 |
| Days to Decision | 248 days |
| Submission Type | Abbreviated |
| 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 |