RHINO-LARYNX STROBOSCOPE TYPE 4914

Laryngostroboscope

BRUEL & KJAER INDUSTRI A/S

The following data is part of a premarket notification filed by Bruel & Kjaer Industri A/s with the FDA for Rhino-larynx Stroboscope Type 4914.

Pre-market Notification Details

Device IDK842090
510k NumberK842090
Device Name:RHINO-LARYNX STROBOSCOPE TYPE 4914
ClassificationLaryngostroboscope
Applicant BRUEL & KJAER INDUSTRI A/S 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeEQL  
CFR Regulation Number874.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-24
Decision Date1984-07-18

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