PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR— 510(k) K053609
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K053609 for PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, Substantially Equivalent on 2006-02-28. Applicant: Edwards Lifesciences, LLC.
Clearance details
- Applicant
- Edwards Lifesciences, LLC
- Product code
- Code DQE
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.