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FDA 510(k)

ENDOMED 582

K-Number: K922020 · 1992-09-22

ApplicantHenley Intl.
Decision Date1992-09-22
Product CodeLIH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ENDOMED 582 is the device name listed in this FDA 510(k) record. The listed applicant is Henley Intl.. It received FDA 510(k) clearance on 1992-09-22 under 510(k) number K922020. The device is classified under product code LIH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOMED 582?

ENDOMED 582 is a medical device that received FDA 510(k) clearance on 1992-09-22. The listed applicant is Henley Intl.. The 510(k) number is K922020.

When did ENDOMED 582 receive FDA 510(k) clearance?

ENDOMED 582 received FDA 510(k) clearance on 1992-09-22, under 510(k) number K922020.

Who is the listed applicant for ENDOMED 582?

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

What is the FDA product code for ENDOMED 582?

The FDA product code for ENDOMED 582 is LIH.

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Other records listing Henley Intl. as applicant

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K943449NEUROLOGICAL DIAGNOSTIC DEVICESK926278STAIR CLIMBERK926279UPPER BODY EXERCISERK926287EXERCISE BICYCLEK926314HYDRA FITNESS MODEL 311 TOTAL POWERK926313COMPUTERIZED TESTING AND EXERCISE SYSTEMS

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Related Devices (Code: LIH)

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.

K231575Vecttor VT-300Artaflex, Inc.K202725ETD4000Therasigma, LLCK183692Avid IF2Vision Quest Industries Inc./Dba VQ OrthocareK122944GEMORE TRUE SINE INTERFERENTIAL STIMULATORGemore Technology Co, Ltd.K121662VECTTOR VT-200Alan Neuromedical Technologies, LLCK110509EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908Everyway Medical Instruments Co.,Ltd

Official Source

View on FDA Database →

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

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