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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor,physiological,patient(without arrhythmia detection or alarms)
510(k) Number K060712
Device Name VITELCARE C-TURTLE PATIENT MONITORING SYSTEM
Original Applicant
VISUAL TELECOMMUNICATIONS NETWORK, INC.
8201 greensboro dr., ste. 600
mclean,  VA  22102
Original Contact allen izadpanah
Regulation Number870.2300
Classification Product Code
MWI  
Date Received03/20/2006
Decision Date 04/19/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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