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 IDK182579
510k NumberK182579
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
CorrespondentRonald S. Warren
Experien Group 224 Airport Parkway, Suite 250 San Jose,  CA  95110
Product CodeDXN  
Subsequent Product CodeDPS
Subsequent Product CodeDXH
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-19
Decision Date2019-03-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10073796267909 K182579 000
10073796343924 K182579 000
10073796341722 K182579 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.