510(k) K183649
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 2019
- Date Received
- December 26, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device Class
- Class II
- Regulation Number
- 870.1220
- Review Panel
- CV
- Submission Type