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FDA 510(k)

VIDEO EYE TRAKKER

K-Number: K964646 · 1997-07-15

ApplicantMicromedical Technologies, Inc.
Decision Date1997-07-15
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VIDEO EYE TRAKKER is the device name listed in this FDA 510(k) record. The listed applicant is Micromedical Technologies, Inc.. It received FDA 510(k) clearance on 1997-07-15 under 510(k) number K964646. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDEO EYE TRAKKER?

VIDEO EYE TRAKKER is a medical device that received FDA 510(k) clearance on 1997-07-15. The listed applicant is Micromedical Technologies, Inc.. The 510(k) number is K964646.

When did VIDEO EYE TRAKKER receive FDA 510(k) clearance?

VIDEO EYE TRAKKER received FDA 510(k) clearance on 1997-07-15, under 510(k) number K964646.

Who is the listed applicant for VIDEO EYE TRAKKER?

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

What is the FDA product code for VIDEO EYE TRAKKER?

The FDA product code for VIDEO EYE TRAKKER is GWN.

Related Clinical Trials

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.

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Other records listing Micromedical Technologies, 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.

K964325VISUALEYES: VIDEO EYE MONITORK922037SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIRK891008VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)K863424COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE

Related Devices (Code: GWN)

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.

K260566SMARTVERTIGO™ Vestibular Assessment SystemVertigoDx, Inc.K243709NeuroEars-Anna™Neuroears, Inc.K242198ICS Dizcovery (1091)Natus Medical Denmark ApsK242726Synapsys VHITInventis S.R.L.K223047NeuroSwift ProNeurobit Technologies Co., Ltd.K203082Insight Infrared Video GogglesVestibular First

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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