LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100

Device, Medical Examination, Ac Powered

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Ls100 Halogen Examination Light, Model No: 44100.

Pre-market Notification Details

Device IDK921493
510k NumberK921493
Device Name:LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100
ClassificationDevice, Medical Examination, Ac Powered
Applicant WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
ContactJohn Watkins
CorrespondentJohn Watkins
WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
Product CodeKZF  
CFR Regulation Number880.6320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-30
Decision Date1992-11-03

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