The following data is part of a premarket notification filed by Abbott (st. Jude Medical) with the FDA for Confirm Rx Insertable Cardiac Monitor.
| Device ID | K202876 |
| 510k Number | K202876 |
| Device Name: | Confirm Rx 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 | 2020-09-28 |
| Decision Date | 2020-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067034304 | K202876 | 000 |