YELLOW 560 Fluorescence Module

System, X-ray, Angiographic

Carl Zeiss Meditec AG

The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Yellow 560 Fluorescence Module.

Pre-market Notification Details

Device IDK162991
510k NumberK162991
Device Name:YELLOW 560 Fluorescence Module
ClassificationSystem, X-ray, Angiographic
Applicant Carl Zeiss Meditec AG Goeschwitzer Str. 51-52 Jena,  DE 07745
ContactPeter Schrutka-rechtenstamm
CorrespondentMandy Ambrecht
Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin,  CA  94568
Product CodeIZI  
CFR Regulation Number892.1600 [🔎]
DecisionSubstantially Equivalent - With Drug (SESD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2016-10-27
Decision Date2017-07-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049539104359 K162991 000

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