Cleared Traditional

PORTAREM 2000

K943460 · Starkey Laboratories, Inc. · Ear, Nose, Throat
Oct 1994
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K943460 is an FDA 510(k) clearance for the PORTAREM 2000, a Calibrator, Hearing Aid / Earphone And Analysis Systems (Class II — Special Controls, product code ETW), submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on October 21, 1994, 95 days after receiving the submission on July 18, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3310.

Submission Details

510(k) Number K943460 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 1994
Decision Date October 21, 1994
Days to Decision 95 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

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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