# K041308: Remotenurse Patient Monitoring System

- Pathway: 510(k) (Abbreviated)
- Applicant: Webvmc, LLC
- Decided: Jun 28, 2004 after 42 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K910772 (1991). 20 ancestors in all.
34 later devices descend from it; 3 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030222: NX System, American Telecare, Inc. (2003) Summary page 1.
- K022274: Carecompanion Patient Station & Nurse Station, Neptec Design Group, Ltd. (2003) Summary page 1.

## Most influential descendants
- K080798: Intel Health Guide, Model: PHS6000 (2008), 25 descendants of its own
- K083862: Medapps 2.0 Remote Patient Monitoring System (2009), 12 descendants of its own
- K083115: Modification to Intel Health Guide, Model PHS6000 (2008), 12 descendants of its own
- K101178: Modification to Intel Health Guide PHS6000 (2010), 11 descendants of its own
- K103276: Intel Health Guide (2011), 10 descendants of its own

## Indications for use
The device "RemoteNurseTM Patient Monitoring system' is a monitoring tool prescribed by a licensed physician when time-critical care Is not required, and is indicated for use to provide caregivers remote access to vital sign measurements of patients at home, as captured on commercially available medical devices designed for home use, and transmitted to a database retrieved from a secure website. It is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The device is contraindicated for patients with uncompensated heart failure, patients at high risk of life threatening arrhythmias, patients with recent myocardial infarctions, or patients requiring direct medical supervision or emergency intervention. The device is intended for patients who are willing and capable to self-administrate it. Clinical judgment and experience are required to check and interpret the information delivered. Typical devices that may be connected to RemoteNurseTM Patient Station are: Blood Pressure Monitor, Glucose Meter, Weight Scale, Pulse-oxidation, Peak Flow, ECG and PT/INR. Also, digital camera may be connected to RemoteNuseym Patient Station. The unit supports up to 8 devices in the same time.

Source page: https://510kreport.com/device/K041308
Methodology: https://510kreport.com/methodology