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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
Applicant
VISUAL TELECOMMUNICATIONS NETWORK, INC.
8201 greensboro dr., ste. 600
mclean,  VA  22102
Applicant Contact allen izadpanah
Correspondent
VISUAL TELECOMMUNICATIONS NETWORK, INC.
8201 greensboro dr., ste. 600
mclean,  VA  22102
Correspodent Contact allen izadpanah
Regulation Number870.2300
Classification Product Code
MWI  
Date Received03/16/2006
Decision Date 04/19/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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