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FDA 510(k)

Non-invasive Hemodynamic Blood Pressure Monitor

K-Number: K190893 · 2019-08-07

ApplicantVita-Course Technologies Co., Ltd.
Decision Date2019-08-07
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Non-invasive Hemodynamic Blood Pressure Monitor is a medical device manufactured by Vita-Course Technologies Co., Ltd.. It received FDA 510(k) clearance on 2019-08-07 under approval number K190893. 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 Non-invasive Hemodynamic Blood Pressure Monitor?

Non-invasive Hemodynamic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2019-08-07. It is manufactured by Vita-Course Technologies Co., Ltd.. The 510(k) number is K190893.

When was Non-invasive Hemodynamic Blood Pressure Monitor approved by the FDA?

Non-invasive Hemodynamic Blood Pressure Monitor received FDA 510(k) clearance on 2019-08-07, under approval number K190893.

What company makes Non-invasive Hemodynamic Blood Pressure Monitor?

Non-invasive Hemodynamic Blood Pressure Monitor is manufactured by Vita-Course Technologies Co., Ltd..

What is the FDA product code for Non-invasive Hemodynamic Blood Pressure Monitor?

The FDA product code for Non-invasive Hemodynamic Blood Pressure Monitor is DXN.

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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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