EV1000 CLINICAL PLATFORM— 510(k) K131892
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K131892 for EV1000 CLINICAL PLATFORM, Substantially Equivalent on 2014-05-22. Applicant: Edwards Lifesciences, LLC.
Clearance details
- Applicant
- Edwards Lifesciences, LLC
- Product code
- Code DXG
- 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.