# K153707: Nihon Kohden Vital Sign Telemeter

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corporation
- Decided: Sep 2, 2016 after 254 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: 5 generations back to K951127 (1995). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080342: Nihon Kohden Bedside Monitor, Model BSM-6000S Series, Nihon Kohden America, Inc. (2008) Summary page 4.
- K043517: Transmitter, ZS-940PA Series, Nihon Kohden America, Inc. (2005) Summary page 4.

## Most influential descendants
- K163459: Nihon Kohden Vital Sign Telemeter (2017), 0 descendants of its own

## Indications for use
The Nihon Kohden Vital Sign Telemeters GZ-120P and GZ-130P are intended to monitor and transmit physiological data from a patient to a Nihon Kohden monitor via radiofrequency in the 802.11 band for continuous monitoring. Both GZ-120P and GZ-130P transmit electrocardiogram (ECG) and respiration data, and GZ-130P transmits blood oxygen saturation (SpO2) in addition. The device may generate an audible and/or visible alarm when an arrhythmia exists, when a measured physiological rate falls outside preset limits, or when a technical error is detected. Furthermore, the devices can be configured for use as a temporary simple monitor to display the patient’s vital signs on the device screens and generate alarms without transmitting the data to other Nihon Kohden monitor. The devices are intended to be used by qualified medical personnel within a medical facility, such as hospital or clinic, on all patient populations including adult, neonate, infant, child, and adolescent subgroups.

Source page: https://510kreport.com/device/K153707
Methodology: https://510kreport.com/methodology