QUATERA 700

Unit, Phacofragmentation

Carl Zeiss Meditec AG

The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Quatera 700.

Pre-market Notification Details

Device IDK212241
510k NumberK212241
Device Name:QUATERA 700
ClassificationUnit, Phacofragmentation
Applicant Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 Jena,  DE 07745
ContactHans-Joachim Miesner
CorrespondentMaria Golovina
Carl Zeiss Meditec Inc 5300 Central Parkway Dublin,  CA  94568
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-19
Decision Date2022-04-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049539104533 K212241 000
04049539100177 K212241 000
04049539102683 K212241 000
04049539102645 K212241 000
04049539100504 K212241 000
04049539103871 K212241 000
04049539103888 K212241 000
04049539103895 K212241 000
04049539103949 K212241 000
04049539100757 K212241 000
04049539100764 K212241 000
04049539064073 K212241 000

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