HEM-7200-Z (BP742)

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 Hem-7200-z (bp742).

Pre-market Notification Details

Device IDK121932
510k NumberK121932
Device Name:HEM-7200-Z (BP742)
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant OMRON HEALTHCARE, INC. 24301 WOODSAGE DRIVE Bonita Springs,  FL  34134
ContactPaul Dryden
CorrespondentPaul Dryden
OMRON HEALTHCARE, INC. 24301 WOODSAGE DRIVE Bonita Springs,  FL  34134
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-02
Decision Date2012-08-29
Summary:summary

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