MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3

System, Measurement, Blood-pressure, Non-invasive

MICROLIFE INTELLECTUAL PROPERTY GMBH

The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh with the FDA for Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp O3.

Pre-market Notification Details

Device IDK082881
510k NumberK082881
Device Name:MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant MICROLIFE INTELLECTUAL PROPERTY GMBH 55 NORTHERN BOULEVARD SUITE 200 Great Neck,  NY  10021
ContactSusan D Goldstein-falk
CorrespondentSusan D Goldstein-falk
MICROLIFE INTELLECTUAL PROPERTY GMBH 55 NORTHERN BOULEVARD SUITE 200 Great Neck,  NY  10021
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-29
Decision Date2008-11-24
Summary:summary

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