EnSite X EP System

Computer, Diagnostic, Programmable

Abbott Medical

The following data is part of a premarket notification filed by Abbott Medical with the FDA for Ensite X Ep System.

Pre-market Notification Details

Device IDK213364
510k NumberK213364
Device Name:EnSite X EP System
ClassificationComputer, Diagnostic, Programmable
Applicant Abbott Medical 5050 Nathan Ln N Plymouth,  MN  55442
ContactTabitha Payne
CorrespondentTabitha Payne
Abbott Medical 5050 Nathan Ln N Plymouth,  MN  55442
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-12
Decision Date2021-11-11

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