REM440— 510(k) K050496

Substantially Equivalent

Interacoustics A/S, Assens

FDA 510(k) clearance K050496 for REM440, Substantially Equivalent on 2005-04-29. Applicant: Interacoustics A/S, Assens. Device class: 2.

Clearance details

Applicant: Interacoustics A/S, Assens
Product code: Code ETW
Device class: Class 2
Regulation: 21 CFR 874.3310
Advisory panel: Ear, Nose, Throat
Date received: 2005-02-28
Decision date: 2005-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.