510(k) K843718
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1984
- Date Received
- September 24, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
- Device Class
- Class II
- Regulation Number
- 870.1750
- Review Panel
- CV
- Submission Type