# K102106: Nihon Khden Prefense Edns-9000 Series Central Nurse Station

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corp.
- Decided: Dec 17, 2010 after 143 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001433 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073550: Prefense Edns-9000 Series Nurse Central Station, Nihon Kohden America, Inc. (2008) Summary page 1.
- K071058: Multiple Patient Receiver, Model Org-9700A, Nihon Kohden America, Inc. (2007) Summary page 1.

## Indications for use
The Prefense EDNS-9000 Series Central Nurse Station is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The Pretense EDNS-9000 Series Central Nurse Station will display and record physiological data from up to forty telemetry receivers/transmitters and generates an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected. Arrhythmia detection is a function of the telemetry receivers/transmitters. Alarm determination can be configured to be performed by either the Prefense EONS-9000 Series Central Nurse Station or by the telemetry receivers/transmitters.

Source page: https://510kreport.com/device/K102106
Methodology: https://510kreport.com/methodology