K131892

Substantially Equivalent

EV1000 CLINICAL PLATFORM

Applicant
Edwards Lifesciences, LLC
Product code
DXG
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.