ZEISS CATARACT SUITE MARKERLESS

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 Zeiss Cataract Suite Markerless.

Pre-market Notification Details

Device IDK141068
510k NumberK141068
Device Name:ZEISS CATARACT SUITE MARKERLESS
ClassificationBiomicroscope, Slit-lamp, Ac-powered
Applicant CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin,  CA  94568
ContactSarah Harrington
CorrespondentSarah Harrington
CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin,  CA  94568
Product CodeHJO  
Subsequent Product CodeEPT
Subsequent Product CodeHMR
Subsequent Product CodeHRM
Subsequent Product CodeNFJ
CFR Regulation Number886.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-24
Decision Date2014-09-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049539069092 K141068 000

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