510(k) K850077
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 1985
- Date Received
- January 9, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Pacemaker Generator Function
- Device Class
- Class II
- Regulation Number
- 870.3630
- Review Panel
- CV
- Submission Type