Cleared Traditional

PORTAREM-3000, PFS-6000

K964340 · Starkey Laboratories, Inc. · Ear, Nose, Throat
Jan 1997
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K964340 is an FDA 510(k) clearance for the PORTAREM-3000, PFS-6000, a Audiometer (Class II — Special Controls, product code EWO), submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on January 10, 1997, 71 days after receiving the submission on October 31, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K964340 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 1996
Decision Date January 10, 1997
Days to Decision 71 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code EWO — Audiometer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1050