FDA 510(k)

eCareCoordinator

K-Number: K171029 · 2017-07-14

Decision Date2017-07-14

Product CodeDRG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

eCareCoordinator is the device name listed in this FDA 510(k) record. The listed applicant is Visicu, Inc.. It received FDA 510(k) clearance on 2017-07-14 under 510(k) number K171029. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the eCareCoordinator?

eCareCoordinator is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is Visicu, Inc.. The 510(k) number is K171029.

When did eCareCoordinator receive FDA 510(k) clearance?

eCareCoordinator received FDA 510(k) clearance on 2017-07-14, under 510(k) number K171029.

Who is the listed applicant for eCareCoordinator?

The FDA 510(k) record lists Visicu, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eCareCoordinator?

The FDA product code for eCareCoordinator is DRG.

Other records listing Visicu, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211046eCareManager 4.5 K171322eCareManager 4.1 K153156eCareManager 4.0.1

Related Devices (Code: DRG)

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare Corporation K243837iBSMIorbit Digital Technologies Private Limited K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

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.