Philips Cardiac Workstation 5000, Cardiac Workstation 7000
- Registration number
- DE0509939
- Model name
- Cardiac Workstation 5000; Cardiac Workstation 7000
- Model identifier
- 860439; 860441
- Registration date
- October 22, 2024
- Source update date
- April 10, 2026
- Risk class
- Class B
- Product owner
- Philips Medizin Systeme Böblingen GmbH
- Registrant / registration holder
- PHILIPS ELECTRONICS SINGAPORE PTE LTD
The Cardiac Workstation is intended to acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes, and to record, display, analyze and store these ECG signals for review by the user. They are to be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user. The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to over-read and validate (or change) the computer-generated ECG interpretation.
- Product owner address
- Hewlett-Packard Strasse 2, 71034 Böblingen, Germany
- Registrant address
- 622 LORONG 1 TOA PAYOH, Singapore 319763
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.