Cleared Traditional

LARYNGOSTROBOSCOPE

K822523 · Kelleher Corp. · Ear, Nose, Throat
Sep 1982
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K822523 is an FDA 510(k) clearance for the LARYNGOSTROBOSCOPE, a Laryngostroboscope (Class I — General Controls, product code EQL), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1982, 17 days after receiving the submission on August 23, 1982. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4750.

Submission Details

510(k) Number K822523 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 1982
Decision Date September 09, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code EQL — Laryngostroboscope
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4750

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