EPISCLERAL VENOUS PRESSURE

Tonometer, Ac-powered

EYETECH, LLC.

The following data is part of a premarket notification filed by Eyetech, Llc. with the FDA for Episcleral Venous Pressure.

Pre-market Notification Details

Device IDK843354
510k NumberK843354
Device Name:EPISCLERAL VENOUS PRESSURE
ClassificationTonometer, Ac-powered
Applicant EYETECH, LLC. 2042 W. FARRAGUT AVENUE Chicago ,  IL  60625 -
ContactMarek T Mori
CorrespondentMarek T Mori
EYETECH, LLC. 2042 W. FARRAGUT AVENUE Chicago ,  IL  60625 -
Product CodeHKX  
CFR Regulation Number886.1930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-08-27
Decision Date1984-11-19

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