EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System

Computer, Diagnostic, Programmable

Abbott Medical

The following data is part of a premarket notification filed by Abbott Medical with the FDA for Ensite Velocity Cardiac Mapping System, Ensite Precision Cardiac Mapping System.

Pre-market Notification Details

Device IDK201181
510k NumberK201181
Device Name:EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System
ClassificationComputer, Diagnostic, Programmable
Applicant Abbott Medical 5050 Nathan Lane North Nathan Lane North,  MN  55442
ContactCharlie Pickrell
CorrespondentCharlie Pickrell
Abbott Medical 5050 Nathan Lane North Nathan Lane North,  MN  55442
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-30
Decision Date2020-06-26

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