# K061816: Galaxy

- Pathway: 510(k) (Traditional)
- Applicant: Larsen & Toubro Limited
- Decided: Jul 12, 2006 after 14 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: 3 generations back to K952474 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051608: Star 50 Monitoring System, Larsen & Toubro Limited (2005) Summary page 2.
- K012139: Vamos Anesthetic Gas Monitor, Draeger Medical, Inc. (2002) Summary page 2.

## Indications for use
The Galaxy multiparameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (Lead I / 1I / III / V / AVL / AVE / AVR), Plethysmograph, Respiration, Invasive Blood pressure (IBPI & IBP2), Capnography (CO 2) & Anesthesia agents. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Diastolic and Mean), Tempcrature, EtCO 2, FiCO 2 , EtAA and FiAA readings. The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device, which can also be used as a portable device, permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.

Source page: https://510kreport.com/device/K061816
Methodology: https://510kreport.com/methodology