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FDA 510(k)

FOCUS VNG/ENG TYPE 1068

K-Number: K061791 · 2006-07-11

ApplicantGn Otometrics A/S
Decision Date2006-07-11
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FOCUS VNG/ENG TYPE 1068 is the device name listed in this FDA 510(k) record. The listed applicant is Gn Otometrics A/S. It received FDA 510(k) clearance on 2006-07-11 under 510(k) number K061791. 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 FOCUS VNG/ENG TYPE 1068?

FOCUS VNG/ENG TYPE 1068 is a medical device that received FDA 510(k) clearance on 2006-07-11. The listed applicant is Gn Otometrics A/S. The 510(k) number is K061791.

When did FOCUS VNG/ENG TYPE 1068 receive FDA 510(k) clearance?

FOCUS VNG/ENG TYPE 1068 received FDA 510(k) clearance on 2006-07-11, under 510(k) number K061791.

Who is the listed applicant for FOCUS VNG/ENG TYPE 1068?

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

What is the FDA product code for FOCUS VNG/ENG TYPE 1068?

The FDA product code for FOCUS VNG/ENG TYPE 1068 is GWN.

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Other records listing Gn Otometrics 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.

K110286GN OTOMETRICS TYPE 1053 FREEFITK083399ICS CHARTR EP 200K061104SPEECHLINK 100 TYPE 1053K033645OTOFLEX 100 TYE 1012

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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