IOLMASTER 500

Biomicroscope, Slit-lamp, Ac-powered

CARL ZEISS MEDITEC AG

The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Iolmaster 500.

Pre-market Notification Details

Device IDK101182
510k NumberK101182
Device Name:IOLMASTER 500
ClassificationBiomicroscope, Slit-lamp, Ac-powered
Applicant CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin,  CA  94568
ContactJudith A Brimacombe
CorrespondentJudith A Brimacombe
CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin,  CA  94568
Product CodeHJO  
CFR Regulation Number886.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-04-27
Decision Date2010-11-03
Summary:summary

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