K053609
Substantially EquivalentPRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
- Applicant
- Edwards Lifesciences, LLC
- Product 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.