ECareManager 4.5

System, Network And Communication, Physiological Monitors

Visicu, Inc.

The following data is part of a premarket notification filed by Visicu, Inc. with the FDA for Ecaremanager 4.5.

Pre-market Notification Details

Device IDK211046
510k NumberK211046
Device Name:ECareManager 4.5
ClassificationSystem, Network And Communication, Physiological Monitors
Applicant Visicu, Inc. 217 East Redwood Street Baltimore,  MD  21202
ContactJanine Treter
CorrespondentJanine Treter
Visicu, Inc. 217 East Redwood Street Baltimore,  MD  21202
Product CodeMSX  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-08
Decision Date2022-06-03

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