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FDA 510(k)

GN OTOMETRICS TYPE 1053 FREEFIT

K-Number: K110286 · 2011-04-28

ApplicantGn Otometrics A/S
Decision Date2011-04-28
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GN OTOMETRICS TYPE 1053 FREEFIT 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 2011-04-28 under 510(k) number K110286. The device is classified under product code ETW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GN OTOMETRICS TYPE 1053 FREEFIT?

GN OTOMETRICS TYPE 1053 FREEFIT is a medical device that received FDA 510(k) clearance on 2011-04-28. The listed applicant is Gn Otometrics A/S. The 510(k) number is K110286.

When did GN OTOMETRICS TYPE 1053 FREEFIT receive FDA 510(k) clearance?

GN OTOMETRICS TYPE 1053 FREEFIT received FDA 510(k) clearance on 2011-04-28, under 510(k) number K110286.

Who is the listed applicant for GN OTOMETRICS TYPE 1053 FREEFIT?

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 GN OTOMETRICS TYPE 1053 FREEFIT?

The FDA product code for GN OTOMETRICS TYPE 1053 FREEFIT is ETW.

Related Clinical Trials

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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.

K083399ICS CHARTR EP 200K061791FOCUS VNG/ENG TYPE 1068K061104SPEECHLINK 100 TYPE 1053K033645OTOFLEX 100 TYE 1012

Related Devices (Code: ETW)

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.

K122028AURICAL HITGn OtometricsK113831PRIMUS HEARING INSTRUMENT TEST UNITAuditdata A/SK093006FONIX ,MODEL 8000Frye Electronics, Inc.K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)Siemens Hearing Instruments, Inc.K061104SPEECHLINK 100 TYPE 1053Gn Otometrics A/SK050496REM440Interacoustics A/S, Assens

Official Source

View on FDA Database →

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