510(k) K062331

Device: HIGHPAK-12
Applicant: AD ELEKTRONIK GMBH
510(k) number: K062331
Product code: MPD
Decision: Substantially Equivalent (SESE)
Decision date: 2007-07-10
Date received: 2006-08-10
Regulation: 870.5300
Classification name: Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: GREGORY J MATHISON
Address: 3924 Cascade Beach Rd. Lutsen MN US 55612 55612

FDA Registration Numbers#

3015876

Source Documents#

Other 510(k) Records For Product Code MPD #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K253099	LIFEPAK 15 AC Power Adapter (41577-000333)	Physio-Control, Inc.	2025-10-14
K240162	LIFEPAK® 35 AC Power Adapter (41335-000001)	Stryker Physio-Control	2024-04-19

Legacy Summary#

summary

FDA Review#

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