K173232 is an FDA 510(k) clearance for the myMerlin(TM) Mobile Application Model APP1001. This device is classified as a Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) (Class II - Special Controls, product code MXC).
Submitted by St Jude Medical (Sylmar, US). The FDA issued a Cleared decision on November 2, 2017, 29 days after receiving the submission on October 4, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K173232 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 2017 |
| Decision Date | November 02, 2017 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MXC — Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |