The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Mymerlin(tm) Mobile Application Model App1001.
| Device ID | K173232 |
| 510k Number | K173232 |
| Device Name: | MyMerlin(TM) Mobile Application Model APP1001 |
| Classification | Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) |
| Applicant | St. Jude Medical 15900 Valley View Ct. Sylmar, CA 91342 |
| Contact | Jennifer Dunham |
| Correspondent | Jennifer Dunham St. Jude Medical 15900 Valley View Ct. Sylmar, CA 91342 |
| Product Code | MXC |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-04 |
| Decision Date | 2017-11-02 |
| Summary: | summary |