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FDA 510(k)

Hypotension Decision Assist Model HDA-OR2

K-Number: K212529 · 2021-11-23

ApplicantDirected Systems, Ltd.
Decision Date2021-11-23
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Hypotension Decision Assist Model HDA-OR2 is a medical device manufactured by Directed Systems, Ltd.. It received FDA 510(k) clearance on 2021-11-23 under approval number K212529. 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 Model HDA-OR2?

Hypotension Decision Assist Model HDA-OR2 is a medical device that received FDA 510(k) clearance on 2021-11-23. It is manufactured by Directed Systems, Ltd.. The 510(k) number is K212529.

When was Hypotension Decision Assist Model HDA-OR2 approved by the FDA?

Hypotension Decision Assist Model HDA-OR2 received FDA 510(k) clearance on 2021-11-23, under approval number K212529.

What company makes Hypotension Decision Assist Model HDA-OR2?

Hypotension Decision Assist Model HDA-OR2 is manufactured by Directed Systems, Ltd..

What is the FDA product code for Hypotension Decision Assist Model HDA-OR2?

The FDA product code for Hypotension Decision Assist Model HDA-OR2 is DXG.

Related Clinical Trials

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Other Devices by Directed Systems, Ltd.

K190955Hypotension Decision Assist

Related Devices (Code: DXG)

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Official Source

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

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