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HSA · registration DE0509939

Philips Cardiac Workstation 5000, Cardiac Workstation 7000

SingaporeCardiovascularClass BPhilips Medizin Systeme Böblingen GmbH
Official record identity
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
Classification
Risk class
Class B
Official value: CLASS B
Published category
Cardiovascular
Published parties
Registrant / registration holder
PHILIPS ELECTRONICS SINGAPORE PTE LTD
Official description

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.

Additional source fields
Product owner address
Hewlett-Packard Strasse 2, 71034 Böblingen, Germany
Registrant address
622 LORONG 1 TOA PAYOH, Singapore 319763
About this record

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.