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FDA 510(k)

ISEN-Goggles with Data Viewer

K-Number: K163270 · 2017-09-25

ApplicantIsent Tech & Trading Company, Ltd.
Decision Date2017-09-25
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ISEN-Goggles with Data Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Isent Tech & Trading Company, Ltd.. It received FDA 510(k) clearance on 2017-09-25 under 510(k) number K163270. 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 ISEN-Goggles with Data Viewer?

ISEN-Goggles with Data Viewer is a medical device that received FDA 510(k) clearance on 2017-09-25. The listed applicant is Isent Tech & Trading Company, Ltd.. The 510(k) number is K163270.

When did ISEN-Goggles with Data Viewer receive FDA 510(k) clearance?

ISEN-Goggles with Data Viewer received FDA 510(k) clearance on 2017-09-25, under 510(k) number K163270.

Who is the listed applicant for ISEN-Goggles with Data Viewer?

The FDA 510(k) record lists Isent Tech & Trading Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISEN-Goggles with Data Viewer?

The FDA product code for ISEN-Goggles with Data Viewer is GWN.

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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