510(k) K240162
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 2024
- Date Received
- January 22, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator
- Device Class
- Class II
- Regulation Number
- 870.5300
- Review Panel
- CV
- Submission Type