eCareManager 4.1
K-Number: K171322 · 2017-08-03
ApplicantVisicu, Inc.
Decision Date2017-08-03
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
eCareManager 4.1 is a medical device manufactured by Visicu, Inc.. It received FDA 510(k) clearance on 2017-08-03 under approval number K171322. 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 4.1?
eCareManager 4.1 is a medical device that received FDA 510(k) clearance on 2017-08-03. It is manufactured by Visicu, Inc.. The 510(k) number is K171322.
When was eCareManager 4.1 approved by the FDA?
eCareManager 4.1 received FDA 510(k) clearance on 2017-08-03, under approval number K171322.
What company makes eCareManager 4.1?
eCareManager 4.1 is manufactured by Visicu, Inc..
What is the FDA product code for eCareManager 4.1?
The FDA product code for eCareManager 4.1 is MSX.
Other Devices by Visicu, Inc.
Related Devices (Code: MSX)
K153156eCareManager 4.0.1Visicu, Inc.
K160862AirStrip RPMAirstrip Technologies, Inc.
K161164CareEvent inclusive of the CareEvent Mobile Application accessoryPhilips Medical Systems
K162607BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.
K180430Digistat Smart CentralAscom Ums Srl Unipersonale
K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter PackageSnap40, Ltd.
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.