# K062338: Televisit

- Pathway: 510(k) (Traditional)
- Applicant: PHD Medical
- Decided: Oct 25, 2006 after 76 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: 2 generations back to K951193 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043604: Lifeshirt Real-Time with Vivomonitor Software, Vivometrics, Inc. (2005) Summary page 1.
- K060194: March Healthcare Health Monitoring Kit, March Healthcare Corporation (2006) Summary page 1.

## Indications for use
The TELEVISIT software allows healthcare professionals to conduct remote medical check-ups through interactive sessions with patients who have limited mobility or live in remote locations. The TELEVISIT software is intended for the purposes of collecting physiological data such as: Non-Invasive Blood Pressure; Pulse Oximetry, Temperature and Breath Sounds (Auscultation). The software provides physicians with a tool to schedule appointments with remote patients; to initiate and manage a medical check-up session, to provide data acquisition of medical device data, and to view session reports. The intended use of the TELEVISIT software is in hospital/clinical environments with established specialized care providing access to each patient in their home and/or local community health center. TELEVISIT software is a non-invasive medical device, which does not flag any abnormal results from the medical device inputs. The TELEVISIT software does not monitor, assess or diagnose a disease, a disorder, or an abnormal physical state. The intended use for the software is data acquisition and collection only, with no treatment function or danger to the end user. The data obtained from TELEVISIT software can be used only as an aid in the diagnosis and treatment of the patient.

Source page: https://510kreport.com/device/K062338
Methodology: https://510kreport.com/methodology