AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757

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 Automatic Blood Pressure Monitor With Intellisense, Model Hem-757.

Pre-market Notification Details

Device IDK001670
510k NumberK001670
Device Name:AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills,  IL  60061
ContactOsamu Shirasaki
CorrespondentOsamu Shirasaki
OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills,  IL  60061
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-01
Decision Date2000-06-30

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