EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER— 510(k) K060660

Name: FDA 510(k) clearance K060660
Creator: U.S. Food and Drug Administration
Published: 2006-04-25

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K060660 for EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER, Substantially Equivalent on 2006-04-25. Applicant: Edwards Lifesciences, LLC. Device class: 2.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2006-03-13
Decision date: 2006-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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