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FDA 510(k)

COMPUTER DYNO/GONIO/MYO GRAPHY

K-Number: K942965 · 1995-10-07

ApplicantInfotronic Medical Engineering
Decision Date1995-10-07
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COMPUTER DYNO/GONIO/MYO GRAPHY is the device name listed in this FDA 510(k) record. The listed applicant is Infotronic Medical Engineering. It received FDA 510(k) clearance on 1995-10-07 under 510(k) number K942965. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPUTER DYNO/GONIO/MYO GRAPHY?

COMPUTER DYNO/GONIO/MYO GRAPHY is a medical device that received FDA 510(k) clearance on 1995-10-07. The listed applicant is Infotronic Medical Engineering. The 510(k) number is K942965.

When did COMPUTER DYNO/GONIO/MYO GRAPHY receive FDA 510(k) clearance?

COMPUTER DYNO/GONIO/MYO GRAPHY received FDA 510(k) clearance on 1995-10-07, under 510(k) number K942965.

Who is the listed applicant for COMPUTER DYNO/GONIO/MYO GRAPHY?

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

What is the FDA product code for COMPUTER DYNO/GONIO/MYO GRAPHY?

The FDA product code for COMPUTER DYNO/GONIO/MYO GRAPHY is IKN.

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Related Devices (Code: IKN)

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.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, 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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