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FDA 510(k)

Hypotension Decision Assist

K-Number: K190955 · 2019-11-27

ApplicantDirected Systems, Ltd.
Decision Date2019-11-27
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Hypotension Decision Assist is a medical device manufactured by Directed Systems, Ltd.. It received FDA 510(k) clearance on 2019-11-27 under approval number K190955. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hypotension Decision Assist?

Hypotension Decision Assist is a medical device that received FDA 510(k) clearance on 2019-11-27. It is manufactured by Directed Systems, Ltd.. The 510(k) number is K190955.

When was Hypotension Decision Assist approved by the FDA?

Hypotension Decision Assist received FDA 510(k) clearance on 2019-11-27, under approval number K190955.

What company makes Hypotension Decision Assist?

Hypotension Decision Assist is manufactured by Directed Systems, Ltd..

What is the FDA product code for Hypotension Decision Assist?

The FDA product code for Hypotension Decision Assist is DXG.

Related Clinical Trials

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Other Devices by Directed Systems, Ltd.

K212529Hypotension Decision Assist Model HDA-OR2

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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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