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FDA 510(k)

EYESEECAM VHIT

K-Number: K131681 · 2013-09-06

ApplicantInteracoustics A/S
Decision Date2013-09-06
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EYESEECAM VHIT is the device name listed in this FDA 510(k) record. The listed applicant is Interacoustics A/S. It received FDA 510(k) clearance on 2013-09-06 under 510(k) number K131681. 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 EYESEECAM VHIT?

EYESEECAM VHIT is a medical device that received FDA 510(k) clearance on 2013-09-06. The listed applicant is Interacoustics A/S. The 510(k) number is K131681.

When did EYESEECAM VHIT receive FDA 510(k) clearance?

EYESEECAM VHIT received FDA 510(k) clearance on 2013-09-06, under 510(k) number K131681.

Who is the listed applicant for EYESEECAM VHIT?

The FDA 510(k) record lists Interacoustics A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EYESEECAM VHIT?

The FDA product code for EYESEECAM VHIT is GWN.

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Other records listing Interacoustics A/S 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.

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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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