MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C

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 Bp3bs1-3c.

Pre-market Notification Details

Device IDK092456
510k NumberK092456
Device Name:MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant MICROLIFE INTELLECTUAL PROPERTY GMBH MDI CONSULTANTS, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck,  NY  11021
ContactSusan D Goldstein-falk
CorrespondentSusan D Goldstein-falk
MICROLIFE INTELLECTUAL PROPERTY GMBH MDI CONSULTANTS, INC. 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 Received2009-08-10
Decision Date2009-10-23
Summary:summary

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