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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 K885191
Device Name MRL BLOOD PRESSURE MONITOR
Applicant
Medical Research Laboratories, Inc.
6457 W. Howard St.
Niles,  IL  60648
Applicant Contact DILIP MEHTA
Correspondent
Medical Research Laboratories, Inc.
6457 W. Howard St.
Niles,  IL  60648
Correspondent Contact DILIP MEHTA
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/16/1988
Decision Date 05/23/1989
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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