Icare Ic200

Tonometer, Manual

Icare Finland Oy

The following data is part of a premarket notification filed by Icare Finland Oy with the FDA for Icare Ic200.

Pre-market Notification Details

Device IDK190316
510k NumberK190316
Device Name:Icare Ic200
ClassificationTonometer, Manual
Applicant Icare Finland Oy Ayritie 22 Vantaa,  FI 01510
ContactHannes Hyvonen
CorrespondentHannes Hyvonen
Icare Finland Oy Ayritie 22 Vantaa,  FI 01510
Product CodeHKY  
CFR Regulation Number886.1930 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOphthalmic
510k Review PanelOphthalmic
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-13
Decision Date2020-01-14


Device IdentifiersubmissionNumberSupplement
06430033851036 K190316 000
06430033850978 K190316 000
06430033850961 K190316 000

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