EV1000 Clinical Platform— 510(k) K193179

Name: FDA 510(k) clearance K193179
Creator: U.S. Food and Drug Administration
Published: 2019-12-17

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K193179 for EV1000 Clinical Platform, Substantially Equivalent on 2019-12-17. Applicant: Edwards Lifesciences, LLC. Device class: 2.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2019-11-18
Decision date: 2019-12-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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