AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR

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 Auto. Oscillometric Digital Blood Press. Monitor.

Pre-market Notification Details

Device IDK913523
510k NumberK913523
Device Name:AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills,  IL  60061
ContactLee Cobot
CorrespondentLee Cobot
OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills,  IL  60061
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-08
Decision Date1991-11-06

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