Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B

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 Wrist Watch Blood Pressure Monitor Model Bp3gk1-4b.

Pre-market Notification Details

Device IDK211288
510k NumberK211288
Device Name:Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Microlife Intellectual Property GmbH Espenstrasse 139 Widnau,  CH 9443
ContactGerhard Firck
CorrespondentVaibhav Arvind Rajal
mdi Consultants, Inc. 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 Received2021-04-28
Decision Date2021-11-04

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