Cleared Special

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2

K183128 · Abbott · Cardiovascular
Dec 2018
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K183128 is an FDA 510(k) clearance for the EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Abbott (St. Paul, US). The FDA issued a Cleared decision on December 12, 2018, 29 days after receiving the submission on November 13, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K183128 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2018
Decision Date December 12, 2018
Days to Decision 29 days
Submission Type Special
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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