510(k) K100739— VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
Substantially EquivalentEdwards Lifesciences, LLC
Clearance details
- Applicant
- Edwards Lifesciences, LLC
- Product code
- Code KRB
- 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.