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FDA 510(k)

Edwards Algorithm for Measurement of Blood Hemoglobin

K-Number: K230612 · 2023-11-17

ApplicantEdwards Lifesciences, LLC
Decision Date2023-11-17
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Edwards Algorithm for Measurement of Blood Hemoglobin 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 2023-11-17 under 510(k) number K230612. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Edwards Algorithm for Measurement of Blood Hemoglobin?

Edwards Algorithm for Measurement of Blood Hemoglobin is a medical device that received FDA 510(k) clearance on 2023-11-17. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K230612.

When did Edwards Algorithm for Measurement of Blood Hemoglobin receive FDA 510(k) clearance?

Edwards Algorithm for Measurement of Blood Hemoglobin received FDA 510(k) clearance on 2023-11-17, under 510(k) number K230612.

Who is the listed applicant for Edwards Algorithm for Measurement of Blood Hemoglobin?

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 Edwards Algorithm for Measurement of Blood Hemoglobin?

The FDA product code for Edwards Algorithm for Measurement of Blood Hemoglobin is MUD.

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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Other records listing Edwards Lifesciences, LLC 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.

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Related Devices (Code: MUD)

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.

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