Cleared Traditional

AURAL REFLEX INDICATOR

K822566 · Kelleher Corp. · Ear, Nose, Throat
Sep 1982
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K822566 is an FDA 510(k) clearance for the AURAL REFLEX INDICATOR, a Tester, Auditory Impedance (Class II — Special Controls, product code ETY), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982, 21 days after receiving the submission on August 24, 1982. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1090.

Submission Details

510(k) Number K822566 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1982
Decision Date September 14, 1982
Days to Decision 21 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code ETY — Tester, Auditory Impedance
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1090