# K131763: Truscope Series Patient Monitor

- Pathway: 510(k) (Special)
- Applicant: Guangdong Biolight Meditech Co., Ltd.
- Decided: Jul 15, 2013 after 28 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: 16 generations back to K941811 (1994). 93 ancestors in all.
No later device cites it as a predicate yet.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120193: Any View Patient Monitors, Guangdong Biolight Meditech Co., Ltd. (2012) Summary page 3.
- K102040: Patient Monitor, Guangdong Biolight Meditech Co., Ltd. (2010) Summary page 4.
- K100046: M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000, Guangdong Biolight Meditech Co., Ltd. (2010) Summary page 4.

## Indications for use
The Truscope series patient monitors (Truscope Elite AS, Truscope Elite A6, Truscope Elite A5 and Truscope Elite A3) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (HIR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (C02), Anesthetic Gas (AG), Impedance Cardiograph (ICG) and Cerebral State Index (CSI). The arrhythmia detection, ST segment analysis only applied to a single adult patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician. It is not intended for helicopter transport, hospital ambulance, or home use. Truescope Series Patient Monitor (Truscope 11 and MINT) is intended to be used for monitoring,, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG Heart Rate (H-R), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (JBP), carbon dioxide (C02), and Temperature (TEMP) of adult, pediatric and neonatal patient. Truescope Series Patient Monitor (Truscope 11 and MINI) is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance. Note: Truscope MINI does not have functions of Invasive Blood Pressure and Carbon Dioxide Trnaescopc Series Patient Monitor (Truscope Classic) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including 2CQ] Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (C02), and Temperature (TEMP) of adult, pediatric and neonatal patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. They are not intended for helicopter transport or hospital ambulance.

Source page: https://510kreport.com/device/K131763
Methodology: https://510kreport.com/methodology