Cleared Traditional

RHINO-LARYNX STROBOSCOPE TYPE 4914

K842090 · Bruel & Kjaer Industri A/S · Ear, Nose, Throat
Jul 1984
Decision
55d
Days
Class 1
Risk

About This 510(k) Submission

K842090 is an FDA 510(k) clearance for the RHINO-LARYNX STROBOSCOPE TYPE 4914, a Laryngostroboscope (Class I — General Controls, product code EQL), submitted by Bruel & Kjaer Industri A/S (Walker, US). The FDA issued a Cleared decision on July 18, 1984, 55 days after receiving the submission on May 24, 1984. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4750.

Submission Details

510(k) Number K842090 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1984
Decision Date July 18, 1984
Days to Decision 55 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

Similar Devices — EQL Laryngostroboscope

All 7
RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351
K984521 · Richard Wolf Medical Instruments Corp. · Mar 1999
RLS 9100 RHINO-LARYNGEAL STROBOSCOPE
K921184 · Kay Elemetrics Corp. · May 1992
9105 RIGID TELESCOPIC ENDOSCOPE
K921285 · Kay Elemetrics Corp. · May 1992
ENDOSTROBOSCOPE IV
K884933 · Jedmed Instrument Co. · Feb 1989
LARYNGOSTROBOSCOPE
K822523 · Kelleher Corp. · Sep 1982
PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A
K801866 · Pentax Precision Instrument Corp. · Sep 1980