FDA.reportPublic FDA data

BPro® Ambulatory Blood Pressure Monitoring System

Primary DI
08885014410012
Brand
BPro® Ambulatory Blood Pressure Monitoring System
Company
HEALTHSTATS INTERNATIONAL PTE LTD
Model
T6200 Series
Device description
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.
Published
2016-09-20
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
08885014410012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08885014410012088850144100128885014410012

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
+65686583248xxx@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
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
08885014410104BPro® Radial Pulse Wave Acquisition DeviceT6200 Series2016-09-23

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