HEALTHSTATS INTERNATIONAL PTE LTD

Address:BreadTalk IHQ, #09-03,SINGAPORE Central Singapore,SG

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (10)

Premarket Exempt

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BPro BT Radial Pulse Wave Acquisition Device - 08885014410005 Catalog Number :

Device Description : The BPro® BT is used to capture the pulse wave from the radial artery.

Device Class : 2

Duns Number: 628476459

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

BPro® Ambulatory Blood Pressure Monitoring System - 08885014410012 Catalog Number :

Device Description : BPro® Ambulatory Blood Pressure Monitoring System is a noninvasive ambulatory bl BPro® Ambulatory Blood Pressure Monitoring System is a noninvasive ambulatory blood pressure monitoring (ABPM) system based on arterial tonometry at the radial artery and oscillometry at the upper arm. It is used for measuring systolic pressure, diastolic pressure and pulse rate of adults.

Device Class : 2

Duns Number: 628476459

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

MC3100™ Oscillometric Blood Pressure Monitor - 08885014410029 Catalog Number :

Device Description : The MC3100™ is an oscillometric blood pressure monitor for measuring systolic pr The MC3100™ is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and pulse rate.

Device Class : 2

Duns Number: 628476459

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

A-PULSE CASP® Pulse Wave Analysis System - 08885014410036 Catalog Number :

Device Description : The A-PULSE CASP® pulse wave analysis system consists of the BPro® radial pulse The A-PULSE CASP® pulse wave analysis system consists of the BPro® radial pulse wave acquisition device, a blood pressure (BP) calibrator and the A-PULSE CASP® pulse wave application software. The BPro® device is used to capture the pulse wave from the radial artery, and the BP calibrator is used to calibrate the pulse wave. Once the pulse wave is calibrated, the software is used to derive the central aortic systolic pressure, radial augmentation index (rAI) and a range of other pulse wave indices. The software allows the pulse wave, blood pressure readings and pulse rate readings to be displayed, stored and printed. The MC3100™ oscillometric blood pressure monitor, or an equivalent, may be used as the BP calibrator.

Device Class : 2

Duns Number: 628476459

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

A-PULSE CASPro® Central Aortic Systolic Pressure Monitoring Device(Professional) - 08885014410043 Catalog Number :

Device Description : The A-PULSE CASPro® is a noninvasive blood pressure monitoring system designed t The A-PULSE CASPro® is a noninvasive blood pressure monitoring system designed to measure the Central Aortic Systolic Pressure (CASP) and additional arterial pulse waveform related indices based on arterial tonometry at the radial artery of the wrist.

Device Class : 2

Duns Number: 628476459

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

A-PULSE CASPal® Central Aortic Systolic Pressure Monitoring Device - 08885014410050 Catalog Number :

Device Description : The A-PULSE CASPal® is a noninvasive blood pressure monitoring system which is The A-PULSE CASPal® is a noninvasive blood pressure monitoring system which is designed to measure the Central Aortic Systolic Pressure (CASP) based on arterial tonometry at the radial artery of the wrist.

Device Class : 2

Duns Number: 628476459

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

MC3100™+ Oscillometric Blood Pressure Monitor - 08885014410067 Catalog Number :

Device Description : The MC3100™+ is a noninvasive blood pressure monitor for measuring the systolic The MC3100™+ is a noninvasive blood pressure monitor for measuring the systolic pressure, diastolic pressure and pulse rate using the oscillometric method. It has a built-in Bluetooth module for Bluetooth Serial Port Profile communication with application program.

Device Class : 2

Duns Number: 628476459

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

A-PULSE CASPal®+ Central Aortic Systolic Pressure Monitoring Device - 08885014410074 Catalog Number :

Device Description : The A-PULSE CASPal®+ is a noninvasive blood pressure monitoring system which is The A-PULSE CASPal®+ is a noninvasive blood pressure monitoring system which is designed to measure the Central Aortic Systolic Pressure (CASP) based on arterial tonometry at the radial artery of the wrist. It has a built-in Bluetooth module for Bluetooth Serial Port Profile communication with application program.

Device Class : 2

Duns Number: 628476459

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

BProSOftCASP® 24-hour BP/CASP Monitoring System - 08885014410081 Catalog Number :

Device Description : The BProSOftCASP® 24-Hour Ambulatory Blood Pressure and CASP Monitoring System i The BProSOftCASP® 24-Hour Ambulatory Blood Pressure and CASP Monitoring System is a noninvasive ambulatory blood pressure monitoring (ABPM) system based on arterial tonometry at the radial artery and oscillometry at the upper arm. It is used for measuring systolic pressure (SYS), diastolic pressure (DIA), pulse rate (PR) and the Central Aortic Systolic Pressure (CASP) of adults.

Device Class : 2

Duns Number: 628476459

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

BPro BT Ambulatory Blood Pressure Monitoring System - 08885014410098 Catalog Number :

Device Description : The BPro® BT Ambulatory Blood Pressure Monitoring system is a noninvasive ambula The BPro® BT Ambulatory Blood Pressure Monitoring system is a noninvasive ambulatoryblood pressure monitoring system based on arterial tonometry at the radial artery of the wrist with radial pulse waveform acquisition.

Device Class : 2

Duns Number: 628476459

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

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