Cleared Traditional

K953684 - GSI 61 CLINICAL AUDIOMETER
(FDA 510(k) Clearance)

K953684 · Grason-Stadler, Inc. · Ear, Nose, Throat device

Oct 1995

Decision

85d

Days

Class 2

Risk

K953684 is an FDA 510(k) clearance for the GSI 61 CLINICAL AUDIOMETER. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).

Submitted by Grason-Stadler, Inc. (Milford, US). The FDA issued a Cleared decision on October 27, 1995, 85 days after receiving the submission on August 3, 1995.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number	K953684 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 03, 1995
Decision Date	October 27, 1995
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement