Cleared Special

EV1000 Clinical Platform

K193179 · Edwards Lifesciences, LLC · Cardiovascular
Dec 2019
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K193179 is an FDA 510(k) clearance for the EV1000 Clinical Platform, a Computer, Diagnostic, Pre-programmed, Single-function (Class II — Special Controls, product code DXG), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on December 17, 2019, 29 days after receiving the submission on November 18, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number K193179 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2019
Decision Date December 17, 2019
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXG — Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1435

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