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FDA 510(k)

ICS CHARTR EP 200

K-Number: K083399 · 2009-02-20

ApplicantGn Otometrics A/S
Decision Date2009-02-20
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ICS CHARTR EP 200 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 2009-02-20 under 510(k) number K083399. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICS CHARTR EP 200?

ICS CHARTR EP 200 is a medical device that received FDA 510(k) clearance on 2009-02-20. The listed applicant is Gn Otometrics A/S. The 510(k) number is K083399.

When did ICS CHARTR EP 200 receive FDA 510(k) clearance?

ICS CHARTR EP 200 received FDA 510(k) clearance on 2009-02-20, under 510(k) number K083399.

Who is the listed applicant for ICS CHARTR EP 200?

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 ICS CHARTR EP 200?

The FDA product code for ICS CHARTR EP 200 is GWJ.

Related Clinical Trials

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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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 FREEFITK061791FOCUS VNG/ENG TYPE 1068K061104SPEECHLINK 100 TYPE 1053K033645OTOFLEX 100 TYE 1012

Related Devices (Code: GWJ)

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.

K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbHK211147ALGO 7iPath Medical GmbHK193033GSI Audera ProGrason StadlerK163326SmartEPIntelligent Hearing Systems

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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