FDA.reportPublic FDA data

A-PULSE CASP® Pulse Wave Analysis System

Primary DI
08885014410036
Brand
A-PULSE CASP® Pulse Wave Analysis System
Company
HEALTHSTATS INTERNATIONAL PTE LTD
Model
T6400 Series
Device description
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.
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072593000A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWAREHealthstats International Pte. , Ltd.2007-11-15DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08885014410036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08885014410036088850144100368885014410036

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure ambulatory recorderAn electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of blood pressure; it is not intended to detect cardiac arrythmias. The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. The device typically incorporates display and controls and may include a cuff with connection tubing.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+6568583248xxx@xx.xx

Regulatory Flags#

DUNS number
628476459
Device count
1
Combination product
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08885014410005BPro BT Radial Pulse Wave Acquisition DeviceT6200 series2018-08-14
08885014410098BPro BT Ambulatory Blood Pressure Monitoring SystemT6200 series2018-08-14
08885014410012BPro® Ambulatory Blood Pressure Monitoring SystemT6200 Series2016-09-20
08885014410029MC3100™ Oscillometric Blood Pressure MonitorT3100 Series2016-09-23
08885014410043A-PULSE CASPro® Central Aortic Systolic Pressure Monitoring Device(Professional)T7100 Series2016-09-23
08885014410050A-PULSE CASPal® Central Aortic Systolic Pressure Monitoring DeviceT7200 Series2016-09-23
08885014410067MC3100™+ Oscillometric Blood Pressure MonitorT3100 Series2016-09-23
08885014410074A-PULSE CASPal®+ Central Aortic Systolic Pressure Monitoring DeviceT7200 Series2016-09-23
08885014410081BProSOftCASP® 24-hour BP/CASP Monitoring System T6300 Series2016-09-23
08885014410104BPro® Radial Pulse Wave Acquisition DeviceT6200 Series2016-09-23

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