Edwards Lifesciences, LLC · Class II · Cleared Feb 28, 2006
| K-number | K053609 |
| Device name | PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR |
| Applicant | Edwards Lifesciences, LLC |
| Product code | DQE |
| Device class | Class II |
| Decision date | Feb 28, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 870.1230 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov