# K023195: Maglife C/Maglife C Plus

- Pathway: 510(k) (Abbreviated)
- Applicant: Schiller Medical S.A.
- Decided: Jun 3, 2003 after 251 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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.
57 later devices descend from it; 1 cites it directly.
0 of 62 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 1.
- K954120: Model 9500 MR-Compatible Multigas Monitor, Magnetic Resonance Equipment Corp. (1997) Summary page 1.
- K864889: Omni-Trak, Invivo Research Labs, Inc. (1987) Summary page 1.
- (no number) Model 3100 LUXTRON CK: named in the summary without a submission number

## Most influential descendants
- K040915: Magnitude 3150M Mri Patient Monitor, Model 3150M (2004), 56 descendants of its own
- K050399: Mri Compatible Patient Monitoring System, Model 3160 (2005), 55 descendants of its own
- K053462: 3160 Mri Patient Monitoring System (2006), 53 descendants of its own
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) (2007), 40 descendants of its own
- K071655: Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538 (2007), 30 descendants of its own

## Indications for use
The Maglife C is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (Sp02), pulse rate, partial carbon dioxide pressure at the end of expiration (EtC02), nitrous oxide concentration ( O / 0 N 2 0 ) , partial pressure of inspired carbon dioxide (min inspired Con), 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 (Fi02) and temperature tracking in the immediate vicinity of a Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations.

Source page: https://510kreport.com/device/K023195
Methodology: https://510kreport.com/methodology