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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 the device name listed in this FDA 510(k) record. The listed applicant is Directed Systems, Ltd.. It received FDA 510(k) clearance on 2021-11-23 under 510(k) 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. The listed applicant is Directed Systems, Ltd.. The 510(k) number is K212529.

When did Hypotension Decision Assist Model HDA-OR2 receive FDA 510(k) clearance?

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

Who is the listed applicant for Hypotension Decision Assist Model HDA-OR2?

The FDA 510(k) record lists Directed Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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Other records listing Directed Systems, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190955Hypotension Decision Assist

Related Devices (Code: DXG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker MedicalK232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu MedicalK192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SEK193179EV1000 Clinical PlatformEdwards Lifesciences, LLCK190955Hypotension Decision AssistDirected Systems, Ltd.

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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