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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 K142106
Device Name DECISIO HEALTH PATIENT DASHBOARD
Applicant
DECISIO HEALTH, INC.
755 N. MATHILDA AVENUE, SUITE 100
sunnyvale,  CA  94085
Applicant Contact ronald s warren
Correspondent
DECISIO HEALTH, INC.
755 N. MATHILDA AVENUE, SUITE 100
sunnyvale,  CA  94085
Correspondent Contact ronald s warren
Regulation Number870.2300
Classification Product Code
MWI  
Date Received08/01/2014
Decision Date 01/18/2015
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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