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FDA 510(k)

MM-1 MOVEMENT MONITOR

K-Number: K971318 · 1997-07-28

ApplicantAxon Instruments, Inc.
Decision Date1997-07-28
Product CodeGYD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MM-1 MOVEMENT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Axon Instruments, Inc.. It received FDA 510(k) clearance on 1997-07-28 under 510(k) number K971318. 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 MM-1 MOVEMENT MONITOR?

MM-1 MOVEMENT MONITOR is a medical device that received FDA 510(k) clearance on 1997-07-28. The listed applicant is Axon Instruments, Inc.. The 510(k) number is K971318.

When did MM-1 MOVEMENT MONITOR receive FDA 510(k) clearance?

MM-1 MOVEMENT MONITOR received FDA 510(k) clearance on 1997-07-28, under 510(k) number K971318.

Who is the listed applicant for MM-1 MOVEMENT MONITOR?

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

What is the FDA product code for MM-1 MOVEMENT MONITOR?

The FDA product code for MM-1 MOVEMENT MONITOR is GYD.

Related Clinical Trials

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Other records listing Axon Instruments, 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.

K990683AXON MP-1 MICROPOSITIONERK970943GUIDELINE SYSTEM

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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