The following data is part of a premarket notification filed by Abbott (st. Jude Medical) with the FDA for Jot Dx Insertable Cardiac Monitor.
| Device ID | K212206 |
| 510k Number | K212206 |
| Device Name: | Jot Dx Insertable Cardiac Monitor |
| Classification | Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) |
| Applicant | Abbott (St. Jude Medical) 15900 Valley View Ct. Sylmar, CA 91342 |
| Contact | Juni Sarkar |
| Correspondent | Juni Sarkar Abbott (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 | 2021-07-15 |
| Decision Date | 2021-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067040046 | K212206 | 000 |