510(k) K241199
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2025
- Date Received
- April 30, 2024
- 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