Microlife Upper Arm Automatic Digital Blood Pressure Monitor

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.

Pre-market Notification Details

Device IDK143341
510k NumberK143341
Device Name:Microlife Upper Arm Automatic Digital Blood Pressure Monitor
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. STE 200 Great Neck,  NY  11021
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-21
Decision Date2015-04-21
Summary:summary

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