OMRON OSCILLOMETRIC DIGIT BLOOD PRES MONIT-HEM-706

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 Oscillometric Digit Blood Pres Monit-hem-706.

Pre-market Notification Details

Device IDK914823
510k NumberK914823
Device Name:OMRON OSCILLOMETRIC DIGIT BLOOD PRES MONIT-HEM-706
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills,  IL  60061
ContactLee A Cabot
CorrespondentLee A Cabot
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 Received1991-10-25
Decision Date1992-12-23

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