510(k) K190295
K190295 is an FDA 510(k) premarket notification submitted by Abbott (St. Jude Medical) for the device "Confirm Rx Insertable Cardiac Monitor". The FDA issued a decision of Substantially Equivalent on Apr 10, 2019. The device falls under product code MXC (Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)), a Class II device regulated under 21 CFR 870.2800. Abbott (St. Jude Medical) has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 10, 2019
- Date Received
- Feb 11, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type
- 510(k)