Cleared Abbreviated

GSI 2000 MIDDLE EAR ANALYZER

K000097 · Grason-Stadler, Inc. · Ear, Nose, Throat
Apr 2000
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K000097 is an FDA 510(k) clearance for the GSI 2000 MIDDLE EAR ANALYZER, a Tester, Auditory Impedance (Class II — Special Controls, product code ETY), submitted by Grason-Stadler, Inc. (Milford, US). The FDA issued a Cleared decision on April 12, 2000, 90 days after receiving the submission on January 13, 2000. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1090.

Submission Details

510(k) Number K000097 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2000
Decision Date April 12, 2000
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETY — Tester, Auditory Impedance
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1090