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FDA 510(k)

REM440

K-Number: K050496 · 2005-04-29

ApplicantInteracoustics A/S, Assens
Decision Date2005-04-29
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

REM440 is the device name listed in this FDA 510(k) record. The listed applicant is Interacoustics A/S, Assens. It received FDA 510(k) clearance on 2005-04-29 under 510(k) number K050496. 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 REM440?

REM440 is a medical device that received FDA 510(k) clearance on 2005-04-29. The listed applicant is Interacoustics A/S, Assens. The 510(k) number is K050496.

When did REM440 receive FDA 510(k) clearance?

REM440 received FDA 510(k) clearance on 2005-04-29, under 510(k) number K050496.

Who is the listed applicant for REM440?

The FDA 510(k) record lists Interacoustics A/S, Assens as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REM440?

The FDA product code for REM440 is ETW.

Other records listing Interacoustics A/S, Assens 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.

K060539DPOAE20 , ECLIPSEK030016TEOAE25K022728AUDIOTRAVELLER, MODEL AA222

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.K061104SPEECHLINK 100 TYPE 1053Gn Otometrics A/S

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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