510(k) K062331
K062331 is an FDA 510(k) premarket notification submitted by Ad Elektronik GmbH for the device "HIGHPAK-12". The FDA issued a decision of Substantially Equivalent on July 10, 2007. The device falls under product code MPD (Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator), a Class II device regulated under 21 CFR 870.5300. Ad Elektronik GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2007
- Date Received
- August 10, 2006
- 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