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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 K101198
Device Name CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K
Applicant
Computerized Screening, Inc.
9550 Gateway Dr.
Reno,  NV  89521
Applicant Contact SAM KUMAR
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF RONGERO
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/29/2010
Decision Date 08/04/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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