Cleared Traditional

PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A

K801866 · Pentax Precision Instrument Corp. · Ear, Nose, Throat
Sep 1980
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K801866 is an FDA 510(k) clearance for the PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A, a Laryngostroboscope (Class I — General Controls, product code EQL), submitted by Pentax Precision Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980, 42 days after receiving the submission on August 5, 1980. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4750.

Submission Details

510(k) Number K801866 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1980
Decision Date September 16, 1980
Days to Decision 42 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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