Cleared Traditional

EnSite X EP System

K212061 · Abbott · Cardiovascular
Oct 2021
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K212061 is an FDA 510(k) clearance for the EnSite X EP System, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Abbott (St. Paul, US). The FDA issued a Cleared decision on October 22, 2021, 113 days after receiving the submission on July 1, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K212061 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2021
Decision Date October 22, 2021
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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