Edwards Algorithm for Measurement of Blood Hemoglobin— 510(k) K230612

Name: FDA 510(k) clearance K230612
Creator: U.S. Food and Drug Administration
Published: 2023-11-17

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K230612 for Edwards Algorithm for Measurement of Blood Hemoglobin, Substantially Equivalent on 2023-11-17. Applicant: Edwards Lifesciences, LLC. Device class: 2.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code MUD
Device class: Class 2
Regulation: 21 CFR 870.2700
Advisory panel: Cardiovascular
Date received: 2023-03-06
Decision date: 2023-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MUD

product code MUD

Malfunction: 467
Total: 467

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.