Singapore HSA registration DE0509939

Philips Cardiac Workstation 5000, Cardiac Workstation 7000

Singapore flagSingapore·CLASS B·Philips Medizin Systeme Böblingen GmbH·Registered October 22, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0509939
Registration Date
October 22, 2024
Retention Due Date
October 21, 2025
Product 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.
Product Owner
Short Name
Philips Medizin Systeme Böblingen GmbH
Address
Hewlett-Packard Strasse 2, 71034 Böblingen, GERMANY
Registrant
Address
622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
Address
622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763
Model information
Model Name(s)
Cardiac Workstation 5000 Cardiac Workstation 7000
Model Identifier(s)
860439 860441
About this record

Access comprehensive regulatory information for Philips Cardiac Workstation 5000, Cardiac Workstation 7000 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509939 and owned by Philips Medizin Systeme Böblingen GmbH. The device was registered on October 22, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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