The following data is part of a premarket notification filed by Abbott (st. Jude Medical) with the FDA for Mymerlin Mobile Application (android), Mymerlin Mobile Application (ios).
| Device ID | K193310 |
| 510k Number | K193310 |
| Device Name: | MyMerlin Mobile Application (Android), MyMerlin Mobile Application (iOS) |
| Classification | Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) |
| Applicant | Abbott (St. Jude Medical) 15900 Valley View Court Sylmar, CA 91342 |
| Contact | Vanessa Powell |
| Correspondent | Vanessa Powell Abbott (St. Jude Medical) 15900 Valley View Court Sylmar, CA 91342 |
| Product Code | MXC |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-29 |
| Decision Date | 2020-03-17 |