Cleared Traditional

MICROTEK MEDICAL'S SOUND STIKS

K913276 · Microbio-Medics, Inc. · Ear, Nose, Throat
Oct 1991
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K913276 is an FDA 510(k) clearance for the MICROTEK MEDICAL'S SOUND STIKS, a Audiometer (Class II — Special Controls, product code EWO), submitted by Microbio-Medics, Inc. (Memphis, US). The FDA issued a Cleared decision on October 21, 1991, 90 days after receiving the submission on July 23, 1991. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K913276 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1991
Decision Date October 21, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code EWO — Audiometer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1050