# K033305: Infinity Multiview Infinity Telemetry System

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Oct 31, 2003 after 17 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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: 5 generations back to K946306 (1995). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030738: Siemens Multiview Infinity Telemetry System, Siemens Medical Solutions USA, Inc. (2003)
- K023569: Siemens Multiview Workstation Modifications, Siemens Medical Solutions USA, Inc. (2002)
- K980625: Siemens Multiview Workstation Enhanced with Diagnostic Statements (Rest Ecg), Siemens Medical Solutions USA, Inc. (1998) Summary page 1.

## Indications for use
The INFINITY MultiView Workstation, INFINITY Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Draeger Patient Monitoring Systems and recorders. The INFINITY MultiView Workstation with Rest ECG is intended to provide interpretive diagnostic statements and reports when connected to an ECG monitor. Use of the INFINITY MultiView Workstation Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters: Heart rate ECG Arrhythmia Analysis Arterial oxygen saturation Pulse rate ST segment analysis The INFINITY MultiView Workstation (MVWS) Telemetry System with TruST is indicated for use when 12-Lead ECG monitoring with a reduced set of electrodes is desired. Reconstructed leads are intended for real-time assessment of ST segment changes.

Source page: https://510kreport.com/device/K033305
Methodology: https://510kreport.com/methodology