# K970358: Ensemble Central Station Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mennen Medical, Inc.
- Decided: Feb 11, 1998 after 377 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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 K892066 (1989). 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)
- K892066: Horizon Central Station, Mennen Medical, Inc. (1989) Summary page 1.
- K921014: Model M2350A and M2360A Wavevue Central Monitor, Hewlett-Packard Co. (1992) Summary page 1.

## Indications for use
ENSEMBLE includes the essential features of a central station monitor for up to 12 patients. It can display vital signs information collected from bedside patient monitoring devices such as: ECG/Heart Rate, Arrhythmia (basic and extended alarms), ST Segment, Respiration, Temperature, Invasive Blood Pressure, Noninvasive Blood Pressure, Pulse Oximetry, and End Tidal carbon-dioxide. The ENSEMBLE may be used in system application in many different clinical specialties within the hospital.

Source page: https://510kreport.com/device/K970358
Methodology: https://510kreport.com/methodology