Wrist Blood Pressure Monitor Model BP4350

System, Measurement, Blood-pressure, Non-invasive

Omron Healthcare, Inc.

The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Wrist Blood Pressure Monitor Model Bp4350.

Pre-market Notification Details

Device IDK182166
510k NumberK182166
Device Name:Wrist Blood Pressure Monitor Model BP4350
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Omron Healthcare, Inc. 1925 West Field Court, Suite 100 Lake Forest,  IL  60045
ContactRenee Thornborough
CorrespondentRon Warren
Experien Group 224 Airport Parkway, Suite 250 San Jose,  CA  95110
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-10
Decision Date2018-11-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10073796266353 K182166 000
10073796264359 K182166 000

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