The following data is part of a premarket notification filed by Abbott with the FDA for Confirm Rx Insertable Cardiac Monitor.
| Device ID | K182981 |
| 510k Number | K182981 |
| Device Name: | Confirm Rx Insertable Cardiac Monitor |
| Classification | Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) |
| Applicant | Abbott 15900 Valley View Ct. Sylmar, CA 91342 |
| Contact | Laura Sparks |
| Correspondent | Laura Sparks Abbott 15900 Valley View Ct. 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 | 2018-10-29 |
| Decision Date | 2019-03-29 |