510(k) K103783
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 2011
- Date Received
- December 27, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dc-Defibrillator, Low-Energy, (Including Paddles)
- Device Class
- Class II
- Regulation Number
- 870.5300
- Review Panel
- CV
- Submission Type