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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 K093389
Device Name CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK
Applicant
Computerized Screening, Inc.
9550 Gateway Dr.
Reno,  NV  89521
Applicant Contact SAM KUMAR
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131
Correspondent Contact MORTEN CHRISTENSEN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/30/2009
Decision Date 11/17/2009
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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