# K964750: Eagle 4000 Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Marquette Electronics, Inc.
- Decided: Feb 21, 1997 after 87 days
- Product code: LOS
- 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 K921669 (1993). 2 ancestors in all.
115 later devices descend from it; 6 cite it directly.
4 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920790: Marquette Eagle Monitor, Marquette Electronics, Inc. (1994) Summary page 2.
- K921669: Marquette SL Series Transport Remote Acquisition, Marquette Electronics, Inc. (1993) Summary page 2.

## Most influential descendants
- K991735: Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac 8 Electrocardiographs (1999), 81 descendants of its own
- K014108: Mac 5000 Ecg Analysis System (2002), 71 descendants of its own
- K091513: Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and SE-1200 (2009), 32 descendants of its own
- K033492: Modification to Mac 5000 Ecg Analysis System (2003), 31 descendants of its own
- K042177: Modification to Mac 5000 Ecg Analysis System (2004), 30 descendants of its own

## Indications for use
The Marquette Eagle 4000 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 printing of information by a paper recorder. Use of the Marquette Eagle 4000 Patient Monitor is intended for patient populations including: adult, pediatric, and/ or neonatal. Use of the Marquette Eagle 4000 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 4000 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/K964750
Methodology: https://510kreport.com/methodology