Healthstats I N T Pte L T D

FDA Filings

This page includes the latest FDA filings for Healthstats I N T Pte L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3006551178
FEI Number3006551178
NameStephen Gorski
Owner & OperatorHEALTHSTATS INTERNATIONAL PTE. LTD.
Contact AddressBreadTalk IHQ, #09-03 30 Tai Seng Street
SINGAPORE SG-NOTA 534013 SG
Official Correspondent
  • STEPHEN H GORSKI
  • 65-685-83248-x
US Agent
Importing Logistics Registration
ImporterWESTPRIME SYSTEMS INC
Address5751 CHINO AVENUE
Chino, CA 91710 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressS65W35739 Piper Rd
Eagle, WI 53119 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
HEALTHSTATS INTERNATIONAL PTE LTD
BPro® Radial Pulse Wave Acquisition Device 2019-11-08
HEALTHSTATS INTERNATIONAL PTE LTD
BPro BT Ambulatory Blood Pressure Monitoring System 2019-11-08
HEALTHSTATS INTERNATIONAL PTE LTD
BProSOftCASP® 24-hour BP/CASP Monitoring System 2019-11-08
HEALTHSTATS INTERNATIONAL PTE LTD
A-PULSE CASPal®+ Central Aortic Systolic Pressure Monitoring Device 2019-11-08
HEALTHSTATS INTERNATIONAL PTE LTD
MC3100™+ Oscillometric Blood Pressure Monitor 2019-11-08
HEALTHSTATS INTERNATIONAL PTE LTD
A-PULSE CASPal® Central Aortic Systolic Pressure Monitoring Device 2019-11-08
HEALTHSTATS INTERNATIONAL PTE LTD
A-PULSE CASPro® Central Aortic Systolic Pressure Monitoring Device(Professional) 2019-11-08
HEALTHSTATS INTERNATIONAL PTE LTD
A-PULSE CASP® Pulse Wave Analysis System 2019-11-08
HEALTHSTATS INTERNATIONAL PTE LTD
MC3100™ Oscillometric Blood Pressure Monitor 2019-11-08
HEALTHSTATS INTERNATIONAL PTE LTD
BPro® Ambulatory Blood Pressure Monitoring System 2019-11-08
HEALTHSTATS INTERNATIONAL PTE LTD
BPro BT Radial Pulse Wave Acquisition Device 2019-11-08
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
BProSOft BT PC Software2018-07-25
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
BPro BT Ambulatory Blood Pressure Monitoring System2018-07-25
HealthSTATS International Pte Ltd
BPro BT Ambulatory Blood Pressure Monitoring System With BProSoft BT PC Software2018-06-21
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
BProSOft CASP PC Software2014-12-30
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
My-BP BP Management Application Software2014-12-30
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
MC3100+ Monitor2014-12-30
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
Healthstats A-Pulse CASPal Monitor2014-12-30
HEALTHSTATS INTERNATIONAL PTE. LTD.
BPROSOFT CASP PC SOFTWARE2014-03-11
HEALTHSTATS INTERNATIONAL PTE. LTD.
HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE2014-03-04
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
A-Pulse CASPro Model T71002010-06-27
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
A-Pulse CASPpal Model T72002010-06-27
HEALTHSTATS INTERNATIONAL PTE. LTD.
A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T72002010-06-08
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
A-Pulse PC Software2008-12-16
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
A-Pulse Arterial Pulse Waveform Analysis System2008-12-16
HEALTHSTATS INTERNATIONAL PTE. LTD.
A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE2007-11-15
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
Healthstats BProSOft PC Software2007-05-15
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
BPro Ambulatory Blood Pressure Monitoring System2007-05-15
Stephen Gorski [HEALTHSTATS INTERNATIONAL PTE. LTD.]
Bpcalibrator Mc3000/Mc31002007-05-15
HEALTHSTATS INTERNATIONAL PTE. LTD.
HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM2006-04-07
HEALTHSTATS INTERNATIONAL PTE. LTD.
BPCALIBRATOR MC3000/MC31002005-06-24

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