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FDA 510(k)

ORTHOSONIX ENERGEX

K-Number: K013094 · 2001-12-14

ApplicantOrthosonix, Inc.
Decision Date2001-12-14
Product CodeNHH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ORTHOSONIX ENERGEX is the device name listed in this FDA 510(k) record. The listed applicant is Orthosonix, Inc.. It received FDA 510(k) clearance on 2001-12-14 under 510(k) number K013094. 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 ORTHOSONIX ENERGEX?

ORTHOSONIX ENERGEX is a medical device that received FDA 510(k) clearance on 2001-12-14. The listed applicant is Orthosonix, Inc.. The 510(k) number is K013094.

When did ORTHOSONIX ENERGEX receive FDA 510(k) clearance?

ORTHOSONIX ENERGEX received FDA 510(k) clearance on 2001-12-14, under 510(k) number K013094.

Who is the listed applicant for ORTHOSONIX ENERGEX?

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

What is the FDA product code for ORTHOSONIX ENERGEX?

The FDA product code for ORTHOSONIX ENERGEX is NHH.

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Related Devices (Code: NHH)

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.

K042686ENERGEXEnergex Systems, 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.

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