# K972535: Maglife C

- Pathway: 510(k) (Traditional)
- Applicant: Odam
- Decided: Jan 13, 1998 after 189 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 K864889 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950264: Maglife, Odam (1996) Summary page 2.
- K954120: Model 9500 MR-Compatible Multigas Monitor, Magnetic Resonance Equipment Corp. (1997) Summary page 3.
- K864889: Omni-Trak, Invivo Research Labs, Inc. (1987) Summary page 3.

## Indications for use
The Maglife C is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (SpO,), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO,), nitrous oxide concentration (%N D), partial pressure of inspired carbon dioxide (min inspired CO,), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired and expired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (FiO,) in the immediate vicinity of a Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations.

Source page: https://510kreport.com/device/K972535
Methodology: https://510kreport.com/methodology