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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K894945
Device Name NON-INVASIVE BLOOD PRESSURE MODULE
Applicant
Marquette Electronics, Inc.
P.O. Box 9100
100 Marquette Dr.
Jupiter,  FL  33468
Applicant Contact SANDRA SCHICK
Correspondent
Marquette Electronics, Inc.
P.O. Box 9100
100 Marquette Dr.
Jupiter,  FL  33468
Correspondent Contact SANDRA SCHICK
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/03/1989
Decision Date 10/26/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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