Singapore HSA registration DE0016812
SunTech Tango M2 Stress BP Monitor
Singapore·CLASS B·SunTech Medical, Inc.·Registered February 05, 2015Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0016812
- Registration Date
- February 05, 2015
- Change Notification Approval Date
- November 21, 2023
- Retention Due Date
- February 04, 2026
Product description
Tango M2 is a non-invasive blood pressure monitor, with the optional capability to monitor oxygen saturation (SpO2), for use in cardiac or exercise stress testing. It measures and displays a patient's systolic and diastolic blood pressure, and with the SpO2 option, percent oxygen saturation of arterial blood. Use Tango M2 only with adult patients, while they undergo a cardiac or exercise stress test under the supervision of a physician.
Product Owner
- Short Name
- SunTech Medical
- Address
- 507 Airport Boulevard, Suite 117, Morrisville, NC 27560-8200, UNITED STATES
Registrant
- Address
- 2 KALLANG AVENUE, CT HUB, #05-04, SINGAPORE 339407
Importer
- Address
- 2 Kallang Avene, CT Hub, #05-04, SINGAPORE 339407
Model information
- Model Name(s)
- Finger Clip Sensor, SpO2, Purelight, Adult, 1 meter CABLE, ECG, BNC to RS232 ECG trigger cable 4240 to MAX 1 RS232 I/F cable BNC ECG trigger cable RS232 comminucations cable BNC to Phono ECG trigger cable ECG splitter cable Tango to Nihon Kohden 9320 RS232 I/F cable Cable assembly - Tango Cable CASE Analog/Digital ECG Interface 8 pin mini din splitter cable Cable, SpO2,LPXpod, 2m Tango M2 Patient Cable WRIST STRAP BLACK POLE CLAMP ASSY. KIT, T-TUBE, NEW CPC-TO-CPC ABP TTube Orbit K Cuff, Small Adult Orbit K Cuff, Adult Orbit K Cuff, Large Adult Orbit K Cuff - Adult Plus Orbit K Cuff, w/Mic, Small Adult Orbit K Cuff, w/Mic - Adult Orbit K Cuff w/Mic. - Large Adult Orbit K Cuff w/Mic,- Adult Plus LPXpod SpO2 Kit w/adult finger sensor, Tango M2 Tango M2 microphone, 18" Tango M2 Microphone, 12 Single Use Patient Kit - Small Adult Disposable Cuff with Female Quick Connects and Mic Pads Single Use Patient Kit - Adult Disposable Cuff with Female Quick Connects and Mic Pads Single Use Patient Kit - Adult Long Disposable Cuff with Female Quick Connects and Mic Pads Single Use Patient Kit - Large Adult Disposable Cuff with Female Quick Connects and Mic Pads Single Use Patient Kit - Large Adult Long Disposable Cuff with Female Quick Connects and Mic Pads Tango M2 USB Cable Kit Tango M2 Preventative Maintenance Kit Tango M2 WW, w/o ECG, no Power cord Tango M2, ECG, WW, no power cord Tango M2 kit, EU Case Tango M2 kit, UK, Case Tango M2 kit, EU/UK, CardioPerfect Tango M2 kit, QStress/Q4500 Tango M2 kit, WW, Xscribe/StressVue
- Model Identifier(s)
- 52-0003-00 91-0004-00 91-0009-00 91-0010-00 91-0011-00 91-0013-00 91-0018-00 91-0053-00 91-0061-00 91-0065-00 91-0066-00 91-0069-00 91-0125-01 91-0127-00 98-0003-00 98-0008-00 98-0030-00 98-0061-01 98-0061-02 98-0061-03 98-0061-05 98-0062-01 98-0062-02 98-0062-03 98-0062-05 98-0233-01 98-0235-00 98-0235-01 98-0700-01 98-0700-02 98-0700-03 98-0700-04 98-0700-05 98-1010-00 99-0027-39 99-0088-02 99-0088-03 99-0132-09 99-0132-10 99-0132-11 99-0132-16 99-0132-18
About this record
Access comprehensive regulatory information for SunTech Tango M2 Stress BP Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0016812 and owned by SunTech Medical, Inc.. The device was registered on February 05, 2015.
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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