HIGHPAK-12— 510(k) K062331

Substantially Equivalent

Ad Elektronik GmbH

FDA 510(k) clearance K062331 for HIGHPAK-12, Substantially Equivalent on 2007-07-10. Applicant: Ad Elektronik GmbH. Device class: 2.

Clearance details

Applicant: Ad Elektronik GmbH
Product code: Code MPD
Device class: Class 2
Regulation: 21 CFR 870.5300
Advisory panel: Cardiovascular
Date received: 2006-08-10
Decision date: 2007-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lutsen, MN, US

Download summary PDF View on FDA.gov ↗

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