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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transmitters and receivers, physiological signal, radiofrequency
510(k) Number K141706
Device Name ECARE COORDINATOR (ECC)
Applicant
VISICU, INC.
217 E. REDWOOD ST., STE. 1900
baltimore,  MD  21202
Applicant Contact chris ferguson
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
saint paul,  MN  55114
Correspondent Contact mark job
Regulation Number870.2910
Classification Product Code
DRG  
Date Received06/24/2014
Decision Date 09/09/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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