MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC

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 Bp3mc1-pc.

Pre-market Notification Details

Device IDK061471
510k NumberK061471
Device Name:MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant MICROLIFE INTELLECTUAL PROPERTY GMBH 55 NORTHERN BLVD., SUITE 200 Great Neck,  NY  11021
ContactSusan D Goldstein-falk
CorrespondentSusan D Goldstein-falk
MICROLIFE INTELLECTUAL PROPERTY GMBH 55 NORTHERN BLVD., SUITE 200 Great Neck,  NY  11021
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-26
Decision Date2006-09-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00634782075941 K061471 000
00634782075934 K061471 000
00634782576202 K061471 000
00634782576134 K061471 000
00634782562991 K061471 000
00634782058470 K061471 000

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