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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K153156
Device Name eCareManager 4.0.1
Applicant
Visicu, Inc.
217 E. Redwood St., Suite 1900
Baltimore,  MD  21202
Applicant Contact Daniel R. Plonski
Correspondent
Visicu, Inc.
217 E. Redwood St., Suite 1900
Baltimore,  MD  21202
Correspondent Contact Daniel R. Plonski
Regulation Number870.2300
Classification Product Code
MSX  
Date Received11/02/2015
Decision Date 09/30/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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