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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauge, Pressure, Coronary, Cardiopulmonary Bypass
510(k) Number K842194
Device Name PRESSURE MONITOR
Applicant
Norton Texas Medical Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Applicant Contact RICK FOSTER
Correspondent
Norton Texas Medical Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent Contact RICK FOSTER
Regulation Number870.4310
Classification Product Code
DXS  
Date Received06/04/1984
Decision Date 08/27/1984
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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