IOLMaster 700

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 700.

Pre-market Notification Details

Device IDK173771
510k NumberK173771
Device Name:IOLMaster 700
ClassificationBiomicroscope, Slit-lamp, Ac-powered
Applicant Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 Jena,  DE 07445
ContactChristian Muenster
CorrespondentLisa Graney
Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria,  VA  22314
Product CodeHJO  
CFR Regulation Number886.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-11
Decision Date2018-08-24

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