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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 a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2023-11-17 under approval 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. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K230612.

When was Edwards Algorithm for Measurement of Blood Hemoglobin approved by the FDA?

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

What company makes Edwards Algorithm for Measurement of Blood Hemoglobin?

Edwards Algorithm for Measurement of Blood Hemoglobin is manufactured by Edwards Lifesciences, LLC.

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.

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

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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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