Cleared Traditional

K810583 - AUDIOMETER (FDA 510(k) Clearance)

K810583 · Grason-Stadler, Inc. · Ear, Nose, Throat device

Apr 1981

Decision

57d

Days

Class 2

Risk

K810583 is an FDA 510(k) clearance for the AUDIOMETER. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).

Submitted by Grason-Stadler, Inc. (Walker, US). The FDA issued a Cleared decision on April 29, 1981, 57 days after receiving the submission on March 3, 1981.

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

Submission Details

510(k) Number	K810583 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 03, 1981
Decision Date	April 29, 1981
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—