510(k) K122161
K122161 is an FDA 510(k) premarket notification submitted by St Jude Medical for the device "SJM CONFIRM". The FDA issued a decision of Substantially Equivalent on November 28, 2012. The device falls under product code MXC (Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)), a Class II device regulated under 21 CFR 870.2800. St Jude Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 28, 2012
- Date Received
- July 20, 2012
- 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