# K033738: Monitoring System, Model Argus PB-2200

- Pathway: 510(k) (Traditional)
- Applicant: Schiller AG
- Decided: Aug 24, 2004 after 270 days
- Product code: DSK (Computer, Blood-Pressure)
- Device class: 2
- Regulation: 21 CFR 870.1110
- 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 K970879 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012226: Monitoring System,Model Argus PB-1000, Schiller AG (2002) Summary page 1.

## Indications for use
The monitoring system ARGUS PB-2200 is for the monitoring of vital parameters such as: Invasive blood pressure: systolic, diastolic and mean pressure CO2, etCO2 and CO2 ins, main and/or sidestream F102 It will extend the functionality of the existing Argus PB-1000 system (K012226). The system comprises the parameter box PB-1000 and the visualisation unit ARGUS PRO. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the PB-2200. This data is then transmitted to the visualisation unit ARGUS PRO or another generally used PC via the serial interface. All data can be shown and monitored on the ARGUS PRO. The PB-2200 is operated using an internal battery and an external power input (RS 232/12V), which is, like the data transmission, completely separate from the visualisation unit. The ARGUS PRO is powered via the normal mains connection 230V/110V. The system is intended for use in the intensive care unit, in the recovery room, in the operating theatre and during hospital internal transports.

Source page: https://510kreport.com/device/K033738
Methodology: https://510kreport.com/methodology