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Welch Allyn® Q-Stress® Cardiac Stress Testing System - HSA Registration DE0504062

Access comprehensive regulatory information for Welch Allyn® Q-Stress® Cardiac Stress Testing System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504062 and owned by Welch Allyn Inc.. The device was registered on January 23, 2020.

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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CLASS B
DE0504062
Welch Allyn® Q-Stress® Cardiac Stress Testing System
HSA Registration Number: DE0504062
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Product Description

The Q-Stress device is intended to acquire, process, record, archive, analyze, and output electrocardiographic data during physiologic stress testing. The device is intended for use in adult, adolescent, and children patient populations. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician. The device may interface with equipment for pulmonary function testing and other devices, including a treadmill or ergometer for dynamic exercise evaluation, as well as non-invasive blood pressure equipment, functional arterial oxygen saturation (SpO2) equipment, and computer communications equipment. The device is not intended to be used as a vital signs physiological monitor.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0504062
Registration Date
January 23, 2020
Change Notification Approval Date
May 29, 2024
Retention Due Date
January 22, 2026
Product Owner
Short Name
Welch Allyn Inc.
Address
4341 State Street Road, Skaneateles Falls, NY 13153-0220, UNITED STATES
Registrant
Address
1 YISHUN AVENUE 7, SINGAPORE 768923
Importer
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552 192 PANDAN LOOP, PANTECH BUSINESS HUB, #07-22, SINGAPORE 128381 1 YISHUN AVENUE 7, #00-00, SINGAPORE 768923
Model Information
Model Name(s)
WIRELESS ACQ MOD (WAM+) w/o LEAD WIRES WIRELSS ACQ MOD (WAM+) w/o LD WIRES - 2 WAM STRESS KIT WAM Kit with AHA Short Lead Set WAM STRESS KIT IEC SHORT LEAD SET SUNTECH TANGO M2 SPO2 UPGRADE MODULE SUNTECH TANGO M2 BP MONITOR KIT XSCRIBE SUNTECH TANGO M2 BP MONITOR KIT Q-STRESS Quinton Q-Stress Review Quinton Q-Stress Review Quinton Q-Stress Review Quinton Q-Stress Review Quinton Q-Stress Review Quinton Q-Stress Review QS6 REVIEW WKSTN KIT QS6 AM12Q TTL SYS Z200 BCRT AHA XML QS6 AM12Q TTL SYS BCRT AHA DICOM QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM QS6 AM12Q TTL KIT Z200 PCRT AHA XML QS6 AM12Q TTL KIT Z200 BCRT AHA QS6 AM12Q TTL KIT Z200 BCRT IEC XML QS6 AM12Q TTL KIT Z200 BCRT AHA XML QS6 AM12Q TTL KIT Z200 BCRT AHA XML QS6 AM12Q TTL KIT Z200 BCRT AHA DICOM QS6 AM12Q TTL KIT Z200 BCRT IEC XML QS6 AM12Q TTL KIT AHA QS6 AM12Q TTL KIT Z200 BCRT AHA XML QS6 AM12Q TTL KIT AHA QS6 AM12Q TTL KIT AHA QS6 AM12Q TTL KIT AHA QS6 WAM KIT AHA QS6 WAM KIT AHA QS6 WAM TTL SYS Z200 BCRT IEC DICOM QS6 WAM TTL KIT Z200 PCRT AHA DICOM QS6 WAM TTL KIT Z200 PCRT AHA DICOM QS6 WAM TTL KIT Z200 BCRT IEC XML QS6 WAM TTL KIT AHA QS6 WAM TTL KIT Z200 BCRT IEC DICOM QS6 WAM TTL KIT BCRT IEC DICOM QS6 WAM TTL KIT AHA XML QS6 WAM TTL KIT AHA QS6 WAM TTL SYS Z200 BCRT IEC XML QS6 WAM TTL SYS Z200 BCRT IEC DICOM QS6 WAM TTL SYS Z200 BCRT IEC DICOM QS6 WAM SYS Z200 BCRT AHA XML QS6 AM12Q TTL TM55 SYS Z200 PCRT AHA DIC QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM QS6 AM12Q TTL KIT AHA DICOM QS6 AM12Q TM55 SYS Z200 PCRT AHA XML QS6 AM12Q SYS Z200 PCRT AHA XML QS6 AM12Q KIT AHA XML QS6 AM12Q TTL TM55 SYS Z200 PCRT AHA XML QS6 AM12Q TTL SYS Z200 PCRT AHA XML QS6 AM12Q TTL TM55 SYS Z200 PCRT AHA XML QS6 AM12Q TTL SYS Z200 PCRT AHA XML QS6 AM12Q TTL KIT AHA XML QS6 SERVER KIT DICOM
Model Identifier(s)
30012-019-55 30012-019-56 41000-036-50 41000-036-51 41000-036-52 9922-017-52 9922-019-50 9922-020-50 QR-6AA-CAXXX QR-6AA-CXXXX QR-6AB-CAXXX QR-6AB-CXXXX QR-6AC-CAXXX QR-6AC-CXXXX QR-6AC-XXXXX QS-6AB-CEAAA QS-6AB-CGAAB QS-6AC-ACAAB QS-6AC-CCAAB QS-6AC-CDBXA QS-6AC-CEBXX QS-6AC-CECAA QS-6AC-CFAAA QS-6AC-CFBAA QS-6AC-CFBAB QS-6AC-CFEAA QS-6AC-CXAXX QS-6AC-DFBAA QS-6AC-XXAXX QS-6AC-XXBXX QS-6BD-ACAAB QS-6CC-CXBXX QS-6CC-XXBXX QS-6EA-DFEAB QS-6EC-ACDAB QS-6EC-CCDAB QS-6EC-CFEAA QS-6EC-CXDXX QS-6EC-DFEAB QS-6EC-DGEAB QS-6EC-XXDXA QS-6EC-XXDXX QS-6ED-CFEAA QS-6ED-CFEAB QS-6ED-DFEAB QS-6FA-CEDXA QS6-ATTD1 QS6-ATTDX QS6-AXTDS QS6-BLXC1 QS6-BLXCX QS6-BXXCS QS6-MLTC1 QS6-MLTCX QS6-MTTC1 QS6-MTTCX QS6-MXTCS QSERV-6AA-XXXXB