IOLMaster700

Biomicroscope, Slit-lamp, Ac-powered

Carl Zeiss Meditec, Inc.

The following data is part of a premarket notification filed by Carl Zeiss Meditec, Inc. with the FDA for Iolmaster700.

Pre-market Notification Details

Device IDK143275
510k NumberK143275
Device Name:IOLMaster700
ClassificationBiomicroscope, Slit-lamp, Ac-powered
Applicant Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin,  CA  94568 -7562
ContactChristine Dunbar
CorrespondentChristine Dunbar
Carl Zeiss Meditec, Inc. 5160 HACIENDA DRIVE Dublin,  CA  94568 -7562
Product CodeHJO  
CFR Regulation Number886.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-14
Decision Date2015-07-10
Summary:summary

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