EV1000 CLINICAL PLATFORM— 510(k) K110597

Substantially Equivalent

Edwards Lifesciences

FDA 510(k) clearance K110597 for EV1000 CLINICAL PLATFORM, Substantially Equivalent on 2011-06-14. Applicant: Edwards Lifesciences. Device class: 2.

Clearance details

Applicant: Edwards Lifesciences
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2011-03-02
Decision date: 2011-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
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.