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510(k) Data Aggregation
K Number
K171029Device Name
eCareCoordinator
Manufacturer
Visicu Inc.
Date Cleared
2017-07-14
(99 days)
Product Code
DRG
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
Visicu Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
eCareCoordinator and its accessories are indicated for use by patients and by care teams for collecting and reviewing patient data from patients who are capable and willing to engage in use of this software, to transmit medical and non-medical information through integrated technologies.
Device Description
eCareCoordinator (eCC) is a software-only telemedicine system, designed to enable the support of patients in the home setting. eCC is intended to support the clinician with monitoring of remote patients. Clinicians use eCC to manage populations of ambulatory care patients, while keeping primary care physicians informed of patient status. eCC is a software-only device and does not contain any patient-contacting components.
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