# K960272: Eagle 3000/3100 Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Marquette Electronics, Inc.
- Decided: Oct 2, 1996 after 258 days
- Product code: MLD (Monitor, St Segment With Alarm)
- 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 K904789 (1991). 1 ancestor in all.
121 later devices descend from it; 2 cite it directly.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904789: Series 7000 Carbon Dioxide Module, Marquette Electronics, Inc. (1991). Our OCR of the scanned summary read K504789, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Carbon Dioxide Module”.

## Cited in the summary but kept off the family tree
- K920790: Marquette Eagle Monitor, Marquette Electronics, Inc. (1994). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K952474: Eagle 3000 Patient Monitor, Marquette Electronics, Inc. (1995). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K993531: Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX (2000), 119 descendants of its own
- K032733: PM-8000 Patient Monitor, Model 8000 (2004), 88 descendants of its own
- K043348: Modification to PM-8000 Patient Monitor (2005), 87 descendants of its own
- K020550: Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX (2002), 75 descendants of its own
- K053234: PM-9000 Express Patient Monitor (2006), 71 descendants of its own

## Indications for use
The Marquette Eagle 3000 Patient Monitor is designed to monitor and display patient data. Its design allows the operator to adjust parameter alarm settings that would audibly and visually notify the operator when a violation occurs. The option is provided for the printing of information by a paper recorder. Use of the Marquette Eagle 3000 Patient Monitor is intended for patient populations including: adult, pediatric, and/or neonatal. Use of the Marquette Eagle 3000 Patient Monitor is not recommended for use in patient's home or residence, during patient transport, or when it has not been ordered by a physician or other qualified medical personnel. Use of the Marquette Eagle 3000 Patient Monitor is intended for operating room (OR), post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. These departments are typically located in hospitals or may be located in outpatient clinics or free standing surgical centers. It is intended for use by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other hospital personnel trained in the use of the equipment.

Source page: https://510kreport.com/device/K960272
Methodology: https://510kreport.com/methodology