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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 K060820
Device Name CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060
Applicant
Suntech Medical, Inc.
507 Airport Blvd., Suite 117
Morrisville,  NC  27560
Applicant Contact DAVID GALLICK
Correspondent
Suntech Medical, Inc.
507 Airport Blvd., Suite 117
Morrisville,  NC  27560
Correspondent Contact DAVID GALLICK
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
MUD  
Date Received03/27/2006
Decision Date 06/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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