# K073550: Prefense Edns-9000 Series Nurse Central Station

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden America, Inc.
- Decided: Mar 28, 2008 after 101 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: 2 generations back to K001433 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023475: CNS-9700 Series Central Nurse Station and Accessories, Nihon Kohden America, Inc. (2002) Summary page 1.

## Most influential descendants
- K102106: Nihon Khden Prefense Edns-9000 Series Central Nurse Station (2010), 0 descendants of its own

## Indications for use
The Prefense EDNS-9000 Series Central Nurse Station is intended for cardiac and vital signs monitoring for multiple patients. The device will display and record physiological data from telemetry receivers/transmitters and alarms when a measured parameter falls outside a preset limit or when an arrhythmia is detected by the telemetry unit. This product will be available for use by medical personnel on all patient populations with a medical facility.

Source page: https://510kreport.com/device/K073550
Methodology: https://510kreport.com/methodology