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

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.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DXG
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 ↗

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