Icare Ic100

Tonometer, Manual

Icare Finland Oy

The following data is part of a premarket notification filed by Icare Finland Oy with the FDA for Icare Ic100.

Pre-market Notification Details

Device IDK153694
510k NumberK153694
Device Name:Icare Ic100
ClassificationTonometer, Manual
Applicant Icare Finland Oy Ayritie 22 Vantaa,  FI Fi-01510
ContactMatti Tulikoura
CorrespondentMatti Tulikoura
Icare Finland Oy Ayritie 22 Vantaa,  FI Fi-01510
Product CodeHKY  
CFR Regulation Number886.1930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-23
Decision Date2016-04-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06430033850473 K153694 000

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