Cleared Traditional

K951759 - GSI 65 COMPUTERIZED AUDIOMETER
(FDA 510(k) Clearance)

K951759 · Grason-Stadler, Inc. · Ear, Nose, Throat device

Jul 1995

Decision

80d

Days

Class 2

Risk

K951759 is an FDA 510(k) clearance for the GSI 65 COMPUTERIZED 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 July 6, 1995, 80 days after receiving the submission on April 17, 1995.

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

Submission Details

510(k) Number	K951759 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 17, 1995
Decision Date	July 06, 1995
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement