K240177 is an FDA 510(k) clearance for the Zio AT® device (A100A1001). This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by iRhythm Technologies, Inc. (San Francisco, US). The FDA issued a Cleared decision on October 30, 2024, 281 days after receiving the submission on January 23, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K240177 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2024 |
| Decision Date | October 30, 2024 |
| Days to Decision | 281 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 |