FDA 510(k)

ENERGEX

K-Number: K042686 · 2005-06-16

Decision Date2005-06-16

Product CodeNHH

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

ENERGEX is the device name listed in this FDA 510(k) record. The listed applicant is Energex Systems, Inc.. It received FDA 510(k) clearance on 2005-06-16 under 510(k) number K042686. The device is classified under product code NHH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENERGEX?

ENERGEX is a medical device that received FDA 510(k) clearance on 2005-06-16. The listed applicant is Energex Systems, Inc.. The 510(k) number is K042686.

When did ENERGEX receive FDA 510(k) clearance?

ENERGEX received FDA 510(k) clearance on 2005-06-16, under 510(k) number K042686.

Who is the listed applicant for ENERGEX?

The FDA 510(k) record lists Energex Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENERGEX?

The FDA product code for ENERGEX is NHH.

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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Related Devices (Code: NHH)

K013094ORTHOSONIX ENERGEXOrthosonix, Inc.

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.