Cleared Traditional

K902540 - GSI 17 SCREENING AUDIOMETER
(FDA 510(k) Clearance)

K902540 · Grason-Stadler, Inc. · Ear, Nose, Throat device

Jul 1990

Decision

37d

Days

Class 2

Risk

K902540 is an FDA 510(k) clearance for the GSI 17 SCREENING AUDIOMETER. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).

Submitted by Grason-Stadler, Inc. (Littleton, US). The FDA issued a Cleared decision on July 13, 1990, 37 days after receiving the submission on June 6, 1990.

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

Submission Details

510(k) Number	K902540 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 06, 1990
Decision Date	July 13, 1990
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—