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510(k) Data Aggregation
K Number
K040581Device Name
MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM
Manufacturer
VITEL NET
Date Cleared
2004-05-27
(84 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
VITEL NET
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MedVizer™ ViTelCare Patient Monitoring System is intended to be used as a tool for an in-home patient that acquires, accumulates, and transmits a continuous self-assessment of physical condition, and other physiological vital signs information to a healthcare practitioner located remotely from the patient. The patient data is transmitted to the MedVizer™ ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. The healthcare practitioner can contact the patient directly through a videoconference connection. The communication connectivity between patient and healthcare practitioner is via a standard public telecommunications utility to the Internet. Decisions concerning diagnosis and treatment are to be performed by qualified healthcare professionals.
Device Description
MedVizer™ ViTelCare Patient Monitoring System is a PC based telemedicine system adapted to the collection, management, and communication of patient monitoring data from home and group care environments.
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K Number
K000557Device Name
MEDVIZER PACS, MODEL RELEASE 2000
Manufacturer
VITEL NET
Date Cleared
2000-04-24
(66 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
VITEL NET
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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