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FDA 510(k)

eCareManager 4.5

K-Number: K211046 · 2022-06-03

ApplicantVisicu, Inc.
Decision Date2022-06-03
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

eCareManager 4.5 is a medical device manufactured by Visicu, Inc.. It received FDA 510(k) clearance on 2022-06-03 under approval number K211046. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the eCareManager 4.5?

eCareManager 4.5 is a medical device that received FDA 510(k) clearance on 2022-06-03. It is manufactured by Visicu, Inc.. The 510(k) number is K211046.

When was eCareManager 4.5 approved by the FDA?

eCareManager 4.5 received FDA 510(k) clearance on 2022-06-03, under approval number K211046.

What company makes eCareManager 4.5?

eCareManager 4.5 is manufactured by Visicu, Inc..

What is the FDA product code for eCareManager 4.5?

The FDA product code for eCareManager 4.5 is MSX.

Other Devices by Visicu, Inc.

K153156eCareManager 4.0.1 K171322eCareManager 4.1 K171029eCareCoordinator

Related Devices (Code: MSX)

K153156eCareManager 4.0.1Visicu, Inc. K160862AirStrip RPMAirstrip Technologies, Inc. K161164CareEvent inclusive of the CareEvent Mobile Application accessoryPhilips Medical Systems K171322eCareManager 4.1Visicu, Inc. K162607BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K180430Digistat Smart CentralAscom Ums Srl Unipersonale

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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