510(k) K101982
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2010
- Date Received
- July 14, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tester, Pacemaker Electrode Function
- Device Class
- Class II
- Regulation Number
- 870.3720
- Review Panel
- CV
- Submission Type