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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 K043368
Device Name VITELCARE TURTLE, MODEL 400
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 Received12/08/2004
Decision Date 02/01/2005
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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