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FDA 510(k)

HIGHPAK-12

K-Number: K062331 · 2007-07-10

ApplicantAd Elektronik GmbH
Decision Date2007-07-10
Product CodeMPD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HIGHPAK-12 is the device name listed in this FDA 510(k) record. The listed applicant is Ad Elektronik GmbH. It received FDA 510(k) clearance on 2007-07-10 under 510(k) number K062331. The device is classified under product code MPD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIGHPAK-12?

HIGHPAK-12 is a medical device that received FDA 510(k) clearance on 2007-07-10. The listed applicant is Ad Elektronik GmbH. The 510(k) number is K062331.

When did HIGHPAK-12 receive FDA 510(k) clearance?

HIGHPAK-12 received FDA 510(k) clearance on 2007-07-10, under 510(k) number K062331.

Who is the listed applicant for HIGHPAK-12?

The FDA 510(k) record lists Ad Elektronik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIGHPAK-12?

The FDA product code for HIGHPAK-12 is MPD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Ad Elektronik GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K030898MOBILE BATTERY SERVICE STATION (MBSS)

Related Devices (Code: MPD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253099LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc.K240162LIFEPAK® 35 AC Power Adapter (41335-000001)Stryker Physio-Control

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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