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FDA 510(k)

ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER

K-Number: K972631 · 1997-09-22

ApplicantIcs Medical Corp.
Decision Date1997-09-22
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Ics Medical Corp.. It received FDA 510(k) clearance on 1997-09-22 under 510(k) number K972631. 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 ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER?

ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER is a medical device that received FDA 510(k) clearance on 1997-09-22. The listed applicant is Ics Medical Corp.. The 510(k) number is K972631.

When did ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER receive FDA 510(k) clearance?

ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER received FDA 510(k) clearance on 1997-09-22, under 510(k) number K972631.

Who is the listed applicant for ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER?

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

What is the FDA product code for ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER?

The FDA product code for ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER is GWN.

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Other records listing Ics Medical 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.

K011181ICS MEDICAL CHARTR OAE WITH TYMPK002985ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMSK991497ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEMK960097CHARTR EPK931609CHARTR ENG SYSTEMK931608NCA-200

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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