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FDA 510(k)

SPEECHLINK 100 TYPE 1053

K-Number: K061104 · 2006-05-03

ApplicantGn Otometrics A/S
Decision Date2006-05-03
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SPEECHLINK 100 TYPE 1053 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 2006-05-03 under 510(k) number K061104. 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 SPEECHLINK 100 TYPE 1053?

SPEECHLINK 100 TYPE 1053 is a medical device that received FDA 510(k) clearance on 2006-05-03. The listed applicant is Gn Otometrics A/S. The 510(k) number is K061104.

When did SPEECHLINK 100 TYPE 1053 receive FDA 510(k) clearance?

SPEECHLINK 100 TYPE 1053 received FDA 510(k) clearance on 2006-05-03, under 510(k) number K061104.

Who is the listed applicant for SPEECHLINK 100 TYPE 1053?

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 SPEECHLINK 100 TYPE 1053?

The FDA product code for SPEECHLINK 100 TYPE 1053 is ETW.

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 FREEFITK083399ICS CHARTR EP 200K061791FOCUS VNG/ENG TYPE 1068K033645OTOFLEX 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/SK110286GN OTOMETRICS TYPE 1053 FREEFITGn Otometrics A/SK093006FONIX ,MODEL 8000Frye Electronics, Inc.K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)Siemens Hearing Instruments, Inc.K050496REM440Interacoustics A/S, Assens

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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