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FDA 510(k)

ENDODYNE DUAL

K-Number: K840321 · 1984-03-16

ApplicantElmed, Inc.
Decision Date1984-03-16
Product CodeLIH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ENDODYNE DUAL is the device name listed in this FDA 510(k) record. The listed applicant is Elmed, Inc.. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K840321. 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 ENDODYNE DUAL?

ENDODYNE DUAL is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is Elmed, Inc.. The 510(k) number is K840321.

When did ENDODYNE DUAL receive FDA 510(k) clearance?

ENDODYNE DUAL received FDA 510(k) clearance on 1984-03-16, under 510(k) number K840321.

Who is the listed applicant for ENDODYNE DUAL?

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

What is the FDA product code for ENDODYNE DUAL?

The FDA product code for ENDODYNE DUAL is LIH.

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Other records listing Elmed, Inc. 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.

K010465DENSTATK974793ELMED ESU 120 M/M DIGITALK953271ELMED RF-ALERTK952110ELMED THERMO-FLUXK926517ELMED LBC 50-PK932938ELMED ESU 300 M/M AND DIGITAL

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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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