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FDA 510(k)

TREMOR MONITOR

K-Number: K782036 · 1979-01-23

ApplicantColumbus Instruments Intl. Corp.
Decision Date1979-01-23
Product CodeGYD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TREMOR MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Columbus Instruments Intl. Corp.. It received FDA 510(k) clearance on 1979-01-23 under 510(k) number K782036. The device is classified under product code GYD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TREMOR MONITOR?

TREMOR MONITOR is a medical device that received FDA 510(k) clearance on 1979-01-23. The listed applicant is Columbus Instruments Intl. Corp.. The 510(k) number is K782036.

When did TREMOR MONITOR receive FDA 510(k) clearance?

TREMOR MONITOR received FDA 510(k) clearance on 1979-01-23, under 510(k) number K782036.

Who is the listed applicant for TREMOR MONITOR?

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

What is the FDA product code for TREMOR MONITOR?

The FDA product code for TREMOR MONITOR is GYD.

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Other records listing Columbus Instruments Intl. Corp. 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.

K895791OXYMAXK861543CARDIOMAX-IIK861100ISO-THERMEXK771718CARDIOTHERM-500X

Related Devices (Code: GYD)

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.

K262515Kneu Platform (V2)Kneu Health Digital , Ltd.K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care PortalEmpatica S.r.l.K253055Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)Nordic Kinetics ABK250153Neu PlatformNeuhealth Digital , Ltd.K221772NeuroRPMNew Touch Digital, Inc.K220820Parky AppH2o Bilisim Yazilim

Official Source

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