Cleared Traditional

9105 RIGID TELESCOPIC ENDOSCOPE

K921285 · Kay Elemetrics Corp. · Ear, Nose, Throat
May 1992
Decision
72d
Days
Class 1
Risk

About This 510(k) Submission

K921285 is an FDA 510(k) clearance for the 9105 RIGID TELESCOPIC ENDOSCOPE, a Laryngostroboscope (Class I — General Controls, product code EQL), submitted by Kay Elemetrics Corp. (Pine Brook, US). The FDA issued a Cleared decision on May 28, 1992, 72 days after receiving the submission on March 17, 1992. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4750.

Submission Details

510(k) Number K921285 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 1992
Decision Date May 28, 1992
Days to Decision 72 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

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

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