CIRRUS PHOTO

Tomography, Optical Coherence

CARL ZEISS MEDITEC AG

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

Pre-market Notification Details

Device IDK133217
510k NumberK133217
Device Name:CIRRUS PHOTO
ClassificationTomography, Optical Coherence
Applicant CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin,  CA  94568
ContactMandy Ambrecht
CorrespondentMandy Ambrecht
CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin,  CA  94568
Product CodeOBO  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-18
Decision Date2014-03-19
Summary:summary

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