TONOMETER DIATON

Tonometer, Ac-powered

RYAZAN STATE INSTRUMENTS

The following data is part of a premarket notification filed by Ryazan State Instruments with the FDA for Tonometer Diaton.

Pre-market Notification Details

Device IDK060780
510k NumberK060780
Device Name:TONOMETER DIATON
ClassificationTonometer, Ac-powered
Applicant RYAZAN STATE INSTRUMENTS 151 EAST WALNUT STREET Long Beach,  NY  11561
ContactBoris Kun
CorrespondentNeil E Devine
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeHKX  
CFR Regulation Number886.1930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-03-22
Decision Date2006-04-06
Summary:summary

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