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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 K143304
Device Name Sickbay Clinical Platform
Applicant
Medical Informatics Corp
6500 Main Street Suite 1020G
houston,  TX  77030
Applicant Contact ralph krog
Correspondent
OMEDtech, LLC
1725 Signal Ridge Drive, Suite 150
edmond,  OK  73013
Correspondent Contact david makanani
Regulation Number870.2300
Classification Product Code
MWI  
Date Received11/18/2014
Decision Date 05/26/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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