# K973984: Rac 2A Module Housing

- Pathway: 510(k) (Traditional)
- Applicant: Marquette Medical Systems, Inc.
- Decided: Jan 16, 1998 after 88 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- 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 K904789 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960272: Eagle 3000/3100 Patient Monitor, Marquette Electronics, Inc. (1996) Summary page 2.
- K960418: Eagle Patient Monitor, Marquette Electronics, Inc. (1996) Summary page 2.
- K961139: Eagle Patient Monitor Model 3000/3100, Marquette Electronics, Inc. (1996) Summary page 2.
- K943977: Smart Anesthesia Multi-Gas (Sam) Module, Marquette Electronics, Inc. (1995) Summary page 2.
- K950581: Smart Anesthesia Multi-Gas (Sam) Module, Marquette Electronics, Inc. (1995) Summary page 2.

## Cited in the summary but kept off the family tree
- K200598: Voyant Maryland Fusion Device, Applied Medical Resources Corp. (2020). Our OCR of the scanned summary read K200598, which FDA decided on Apr 8, 2020, after this device was decided (Jan 16, 1998), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 2.

## Indications for use
The RAC 2A adds modularity to the Marquette Eagle configured product line. it is used to house the module [SAM (Smart Anesthesia Multi-gas) module] and provides an interface to the Eagle display. The module's patient information may be displayed on the Marquette Eagle monitor. This device is intended to be used by personnel trained in the use of the equipment. It is intended to be used within the hospital/facility environment.

Source page: https://510kreport.com/device/K973984
Methodology: https://510kreport.com/methodology