# K040581: Medvizertm Vitelcare Patient Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Vitel Net
- Decided: May 27, 2004 after 84 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000557 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000557: Medvizer Pacs, Model Release 2000, Vitel Net (2000) Summary page 1.

## Most influential descendants
- K043368: Vitelcare Turtle, Model 400 (2005), 1 descendant of its own
- K060712: Vitelcare C-Turtle Patient Monitoring System (2006), 0 descendants of its own

## Indications for use
MedVizerTM ViTelCare Patient Monitoring System is intended to be a communication tool for an in-home patient that acquires, accumulates, and transmits vital signs information, self-assessment of physical condition, and other physiological data to a healthcare practitioner located remotely from the patient. The patient information is received and stored on the MedVizerrM 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 when desired. 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.

Source page: https://510kreport.com/device/K040581
Methodology: https://510kreport.com/methodology