FDA 510(k)

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index

K-Number: K203687 · 2021-05-28

Decision Date2021-05-28

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2021-05-28 under 510(k) number K203687. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index?

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index is a medical device that received FDA 510(k) clearance on 2021-05-28. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K203687.

When did HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index receive FDA 510(k) clearance?

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index received FDA 510(k) clearance on 2021-05-28, under 510(k) number K203687.

Who is the listed applicant for HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index?

The FDA product code for HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index is DQK.

Related Clinical Trials

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.

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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.