FDA.reportPublic FDA data

BPro® Radial Pulse Wave Acquisition Device

Primary DI
08885014410104
Brand
BPro® Radial Pulse Wave Acquisition Device
Company
HEALTHSTATS INTERNATIONAL PTE LTD
Model
T6200 Series
Device description
The BPro® device is designed to be worn like a wristwatch and to function as a blood pressure monitor.
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
K060315000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060315000HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEMHealthstats International Pte. , Ltd.2006-04-07DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08885014410104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08885014410104088850144101048885014410104

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
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
08885014410036A-PULSE CASP® Pulse Wave Analysis SystemT6400 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

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Primary DI, Brand, Company table
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