Omron Model BP7900 Blood Pressure Monitor + EKG

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 Omron Model Bp7900 Blood Pressure Monitor + Ekg.

Pre-market Notification Details

Device IDK202228
510k NumberK202228
Device Name:Omron Model BP7900 Blood Pressure Monitor + EKG
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Omron Healthcare, Inc. 1925 West Field Court, Suite 100 Lake Forest,  IL  60045
ContactRenee Thornborough
CorrespondentKit Cariquitan
Experien Group 224 Airport Parkway Suite 250 San Jose,  CA  95110
Product CodeDXN  
Subsequent Product CodeDPS
Subsequent Product CodeDXH
Subsequent Product CodeQDA
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-07
Decision Date2021-04-01

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