SLIT LAMP, H-201

Biomicroscope, Slit-lamp, Ac-powered

CANON U.S.A., INC.

The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Slit Lamp, H-201.

Pre-market Notification Details

Device IDK936209
510k NumberK936209
Device Name:SLIT LAMP, H-201
ClassificationBiomicroscope, Slit-lamp, Ac-powered
Applicant CANON U.S.A., INC. ONE CANON PLAZA Lake Success,  NY  11042 -1198
ContactKoichi Yano
CorrespondentKoichi Yano
CANON U.S.A., INC. ONE CANON PLAZA Lake Success,  NY  11042 -1198
Product CodeHJO  
CFR Regulation Number886.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-29
Decision Date1994-04-01

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