MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR

System, Measurement, Blood-pressure, Non-invasive

MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND

The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh, Switzerland with the FDA for Microlife Upper Arm Automatic Digital Blood Pressure Monitor.

Pre-market Notification Details

Device IDK140572
510k NumberK140572
Device Name:MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND 55 NORTHERN BLVD. SUITE 200 Great Neck,  NY  11021
ContactSusan D Goldstein-falk
CorrespondentSusan D Goldstein-falk
MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND 55 NORTHERN BLVD. SUITE 200 Great Neck,  NY  11021
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-06
Decision Date2014-07-02
Summary:summary

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