ECARE COORDINATOR (ECC)

Transmitters And Receivers, Physiological Signal, Radiofrequency

VISICU, INC.

The following data is part of a premarket notification filed by Visicu, Inc. with the FDA for Ecare Coordinator (ecc).

Pre-market Notification Details

Device IDK141706
510k NumberK141706
Device Name:ECARE COORDINATOR (ECC)
ClassificationTransmitters And Receivers, Physiological Signal, Radiofrequency
Applicant VISICU, INC. 217 E. REDWOOD ST., STE. 1900 Baltimore,  MD  21202
ContactChris Ferguson
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDRG  
CFR Regulation Number870.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2014-06-24
Decision Date2014-09-09
Summary:summary

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