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FDA 510(k)

BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software

K-Number: K173028 · 2018-06-21

ApplicantHealthstats International Pte. , Ltd.
Decision Date2018-06-21
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software is a medical device manufactured by Healthstats International Pte. , Ltd.. It received FDA 510(k) clearance on 2018-06-21 under approval number K173028. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software?

BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software is a medical device that received FDA 510(k) clearance on 2018-06-21. It is manufactured by Healthstats International Pte. , Ltd.. The 510(k) number is K173028.

When was BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software approved by the FDA?

BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software received FDA 510(k) clearance on 2018-06-21, under approval number K173028.

What company makes BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software?

BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software is manufactured by Healthstats International Pte. , Ltd..

What is the FDA product code for BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software?

The FDA product code for BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software is DXN.

Related Clinical Trials

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Related PubMed Literature

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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