BLOOD PRESSURE METER, MODEL CH-609

System, Measurement, Blood-pressure, Non-invasive

CITIZEN SYSTEMS JAPAN CO., LTD.

The following data is part of a premarket notification filed by Citizen Systems Japan Co., Ltd. with the FDA for Blood Pressure Meter, Model Ch-609.

Pre-market Notification Details

Device IDK100055
510k NumberK100055
Device Name:BLOOD PRESSURE METER, MODEL CH-609
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant CITIZEN SYSTEMS JAPAN CO., LTD. 3000 K STREET NW SUITE 600 Washington,  DC  20007 -5143
ContactNathan A Beaver
CorrespondentNathan A Beaver
CITIZEN SYSTEMS JAPAN CO., LTD. 3000 K STREET NW SUITE 600 Washington,  DC  20007 -5143
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-08
Decision Date2010-08-30

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