OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N

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 Digital Wrist Blood Pressure Monitor, Model Hem-609n.

Pre-market Notification Details

Device IDK042505
510k NumberK042505
Device Name:OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills,  IL  60061
ContactIwao Kojima
CorrespondentIwao Kojima
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 Received2004-09-15
Decision Date2005-04-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00073796832117 K042505 000
00073796652319 K042505 000

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