K060660

Substantially Equivalent

EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER

Applicant: Edwards Lifesciences, LLC
Product 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.