510(k) K040812
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2004
- Date Received
- March 29, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Pacemaker, Temporary
- Device Class
- Class II
- Regulation Number
- 870.3680
- Review Panel
- CV
- Submission Type