Cleared Traditional

REM440

K050496 · Interacoustics A/S, Assens · Ear, Nose, Throat
Apr 2005
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K050496 is an FDA 510(k) clearance for the REM440, a Calibrator, Hearing Aid / Earphone And Analysis Systems (Class II — Special Controls, product code ETW), submitted by Interacoustics A/S, Assens (Eden Prairie, US). The FDA issued a Cleared decision on April 29, 2005, 60 days after receiving the submission on February 28, 2005. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3310.

Submission Details

510(k) Number K050496 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2005
Decision Date April 29, 2005
Days to Decision 60 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code ETW — Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3310

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