Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y

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 Bp3mw1-4y.

Pre-market Notification Details

Device IDK172498
510k NumberK172498
Device Name:Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Microlife Intellectual Property GmbH Espenstrasse 139 Widnau,  CH 9443
ContactGerhard Frick
CorrespondentSusan D. Goldstein-falk
mdi Consultants, Inc. 55 Northern Blvd. Great Neck,  NY  11021
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-18
Decision Date2017-10-13
Summary:summary

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