510(k) K233562
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 2023
- Date Received
- November 6, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type