Cleared Traditional

NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING

K822269 · Kelleher Corp. · Ear, Nose, Throat
Sep 1982
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K822269 is an FDA 510(k) clearance for the NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING, a Chamber, Acoustic (for Audiometric Testing) (Class I — General Controls, product code EWC), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1982, 42 days after receiving the submission on July 29, 1982. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1060.

Submission Details

510(k) Number K822269 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1982
Decision Date September 09, 1982
Days to Decision 42 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code EWC — Chamber, Acoustic (for Audiometric Testing)
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.1060