NON-INVASIVE BLOOD PRESSURE MODULE

System, Measurement, Blood-pressure, Non-invasive

MARQUETTE ELECTRONICS, INC.

The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Non-invasive Blood Pressure Module.

Pre-market Notification Details

Device IDK894945
510k NumberK894945
Device Name:NON-INVASIVE BLOOD PRESSURE MODULE
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant MARQUETTE ELECTRONICS, INC. P.O. BOX 9100 100 MARQUETTE DRIVE Jupiter,  FL  33468
ContactSandra Schick
CorrespondentSandra Schick
MARQUETTE ELECTRONICS, INC. P.O. BOX 9100 100 MARQUETTE DRIVE Jupiter,  FL  33468
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-03
Decision Date1989-10-26

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