# K040395: Central Telemetry System, Model Wep-4200A Series

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Jun 1, 2004 after 105 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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 K945944 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945944: Nihon Kohden Wep-8430A Central Telemetry System, Nihon Kohden America, Inc. (1995) Summary page 1.
- K001693: Life Scope P, Model BSM-4100 Series, Nihon Kohden America, Inc. (2000) Summary page 1.

## Indications for use
The device is comprised of transmitters and a receiver communicated via WMTS radio frequency. The series of device are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. The device is also intended to monitor patients' physiological data including heart rate, pulse rate, blood oxygen saturation (SpO2) noninvasive blood pressure (NIBP), body temperature respiratory rate and apnea. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device receives physiological signals via radio frequency from the transmitters. The device has the capability of communicating with external devices, such as personal computers. Vital sign data can be sent to a central monitor through the network via network card. The device will be available for use by medical personnel on patients within a medical facility including adults, children and infants.

Source page: https://510kreport.com/device/K040395
Methodology: https://510kreport.com/methodology