Philips PageWriter TC10 - HSA Registration DE0503640
Access comprehensive regulatory information for Philips PageWriter TC10 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503640 and owned by Philips Medizin Systeme Böblingen GmbH. The device was registered on September 25, 2019.
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.
The intended use of the cardiograph is 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. The cardiograph is to be used 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 overread and validate (or change) the computer-generated ECG interpretation.