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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 K113835
Device Name DATACAPTOR SYSTEM
Original Applicant
CAPSULE TECH INC.
300 brickstone square
suite 203
andover,  MA  01810
Original Contact peter kelley
Regulation Number870.2300
Classification Product Code
MWI  
Date Received12/27/2011
Decision Date 06/27/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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