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FDA 510(k)

ISODYNE

K-Number: K770558 · 1977-04-05

ApplicantHmw Industries
Decision Date1977-04-05
Product CodeECO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ISODYNE is the device name listed in this FDA 510(k) record. The listed applicant is Hmw Industries. It received FDA 510(k) clearance on 1977-04-05 under 510(k) number K770558. The device is classified under product code ECO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISODYNE?

ISODYNE is a medical device that received FDA 510(k) clearance on 1977-04-05. The listed applicant is Hmw Industries. The 510(k) number is K770558.

When did ISODYNE receive FDA 510(k) clearance?

ISODYNE received FDA 510(k) clearance on 1977-04-05, under 510(k) number K770558.

Who is the listed applicant for ISODYNE?

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

What is the FDA product code for ISODYNE?

The FDA product code for ISODYNE is ECO.

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Related Devices (Code: ECO)

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.

K943068MAGNEFORCEOrmco Corp.K933542MESIAL LOOP BARGac Intl., Inc.K942492ADJUSTABLE BITE CORRECTOROrthoplus, Inc.K844234ACTIVE VERTICAL CORRECTOR APPLIANCEActive Vertical Correctors, Inc.K843550ORTHOMAG MAGNETIC FORCE SYSTEMMedical Magnetics, Inc.K843344ACTIVE VERTICAL CORRECTOR ACTIVE BITEActive Vertical Correctors, 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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