EW200 System (Oxygen Saturation Monitoring System) and Presep Oximetry Catheter
FDA 510(k) K060660 · Edwards Lifesciences, LLC
510(k) numberK060660
Submission
- Device name
- EW200 System (Oxygen Saturation Monitoring System) and Presep Oximetry Catheter
- Applicant
- Edwards Lifesciences, LLC
Irvine, CA, US - Received
- March 13, 2006
- Decision date
- April 25, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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Questions and answers
When was EW200 System (Oxygen Saturation Monitoring System) and Presep Oximetry Catheter cleared by the FDA?
EW200 System (Oxygen Saturation Monitoring System) and Presep Oximetry Catheter (K060660) received a 510(k) decision of Substantially Equivalent on April 25, 2006, 43 days after the submission was received.
What is the product code of K060660?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.