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 IDK202729
510k NumberK202729
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
CorrespondentVaibhav Arvind Rajal
mdi Consutants Inc. 55 Northem Blvd, Suite 200 Great Neck,  NY  11021
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-18
Decision Date2021-04-08

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