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FDA 510(k)

Acumen Assisted Fluid Management (AFM) Software Feature

K-Number: K233984 · 2024-08-02

ApplicantEdwards Lifesciences, LLC
Decision Date2024-08-02
Product CodeQMS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Acumen Assisted Fluid Management (AFM) Software Feature 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 2024-08-02 under 510(k) number K233984. The device is classified under product code QMS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acumen Assisted Fluid Management (AFM) Software Feature?

Acumen Assisted Fluid Management (AFM) Software Feature is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K233984.

When did Acumen Assisted Fluid Management (AFM) Software Feature receive FDA 510(k) clearance?

Acumen Assisted Fluid Management (AFM) Software Feature received FDA 510(k) clearance on 2024-08-02, under 510(k) number K233984.

Who is the listed applicant for Acumen Assisted Fluid Management (AFM) Software Feature?

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 Acumen Assisted Fluid Management (AFM) Software Feature?

The FDA product code for Acumen Assisted Fluid Management (AFM) Software Feature is QMS.

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Other records listing Edwards Lifesciences, LLC as applicant

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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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