Cleared Traditional

321Q MINIMUM ENERGY TINNITUS SUPPRESSOR

K922572 · Microbio-Medics, Inc. · Ear, Nose, Throat
Nov 1992
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K922572 is an FDA 510(k) clearance for the 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR, a Masker, Tinnitus (Class II — Special Controls, product code KLW), submitted by Microbio-Medics, Inc. (Memphis, US). The FDA issued a Cleared decision on November 2, 1992, 154 days after receiving the submission on June 1, 1992. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number K922572 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 1992
Decision Date November 02, 1992
Days to Decision 154 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code KLW — Masker, Tinnitus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3400