510(k) K863045
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1986
- Date Received
- August 12, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Programmer, Pacemaker
- Device Class
- Class III
- Regulation Number
- 870.3700
- Review Panel
- CV
- Submission Type