Icare HOME Tonometer

Tonometer, Manual

Icare Finland Oy

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

Pre-market Notification Details

Device IDK200966
510k NumberK200966
Device Name:Icare HOME Tonometer
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-10
Decision Date2020-05-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06430033851074 K200966 000
06430033850985 K200966 000
06430033851074 K200966 000
06430033850985 K200966 000
06430033851074 K200966 000
06430033850985 K200966 000

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