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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 K854813
Device Name MEDNOVA BLOOD PRESSURE CUFF
Applicant
Mednova Corp.
C/O Nixon Hargrave Devans Doyl
One Thomas Cir., Suite 800
Washington,  DC  20005
Applicant Contact STEPHEN KURZMAN
Correspondent
Mednova Corp.
C/O Nixon Hargrave Devans Doyl
One Thomas Cir., Suite 800
Washington,  DC  20005
Correspondent Contact STEPHEN KURZMAN
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received12/03/1985
Decision Date 06/20/1986
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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