CORVIS ST

Tonometer, Ac-powered

OCULUS OPTIKGERATE GMBH

The following data is part of a premarket notification filed by Oculus Optikgerate Gmbh with the FDA for Corvis St.

Pre-market Notification Details

Device IDK113066
510k NumberK113066
Device Name:CORVIS ST
ClassificationTonometer, Ac-powered
Applicant OCULUS OPTIKGERATE GMBH MUNCHHOLZHAUSER STR. 29 Wetzlar,  DE D-35582
ContactEckhard Loh
CorrespondentEckhard Loh
OCULUS OPTIKGERATE GMBH MUNCHHOLZHAUSER STR. 29 Wetzlar,  DE D-35582
Product CodeHKX  
CFR Regulation Number886.1930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-17
Decision Date2012-11-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049584014085 K113066 000

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