Cleared Traditional

ENDOSTROBOSCOPE IV

K884933 · Jedmed Instrument Co. · Ear, Nose, Throat
Feb 1989
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K884933 is an FDA 510(k) clearance for the ENDOSTROBOSCOPE IV, a Laryngostroboscope (Class I — General Controls, product code EQL), submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on February 15, 1989, 79 days after receiving the submission on November 28, 1988. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4750.

Submission Details

510(k) Number K884933 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 1988
Decision Date February 15, 1989
Days to Decision 79 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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