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FDA 510(k)

ICS IMPULSE

K-Number: K122550 · 2013-02-01

ApplicantGn Otometrics
Decision Date2013-02-01
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ICS IMPULSE is the device name listed in this FDA 510(k) record. The listed applicant is Gn Otometrics. It received FDA 510(k) clearance on 2013-02-01 under 510(k) number K122550. 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 IMPULSE?

ICS IMPULSE is a medical device that received FDA 510(k) clearance on 2013-02-01. The listed applicant is Gn Otometrics. The 510(k) number is K122550.

When did ICS IMPULSE receive FDA 510(k) clearance?

ICS IMPULSE received FDA 510(k) clearance on 2013-02-01, under 510(k) number K122550.

Who is the listed applicant for ICS IMPULSE?

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

What is the FDA product code for ICS IMPULSE?

The FDA product code for ICS IMPULSE is GWN.

Related Clinical Trials

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Other records listing Gn Otometrics 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.

K161707Madsen ZodiacK122028AURICAL HITK122067TYPE 1077 ACCUSCREENK092373ICS CHARTR EP 200K081234GN OTOMETRICS INSERT EARPHONES

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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