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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K801568
Device Name SHIELD DISPOSABLE BLOOD PRESSURE CUFF
Applicant
American Convertors Div., American Pharmaseal
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Convertors Div., American Pharmaseal
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received07/08/1980
Decision Date 07/28/1980
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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