Cleared Traditional

GSI SA60 DPOAE SYSTEM

K970324 · Grason-Stadler, Inc. · Ear, Nose, Throat
Jun 1997
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K970324 is an FDA 510(k) clearance for the GSI SA60 DPOAE SYSTEM, a Calibrator, Hearing Aid / Earphone And Analysis Systems (Class II — Special Controls, product code ETW), submitted by Grason-Stadler, Inc. (Milford, US). The FDA issued a Cleared decision on June 6, 1997, 130 days after receiving the submission on January 27, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3310.

Submission Details

510(k) Number K970324 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 1997
Decision Date June 06, 1997
Days to Decision 130 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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