Emprint Ablation Visualization Application

System, Image Processing, Radiological

Covidien, LLC

The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Emprint Ablation Visualization Application.

Pre-market Notification Details

Device IDK180192
510k NumberK180192
Device Name:Emprint Ablation Visualization Application
ClassificationSystem, Image Processing, Radiological
Applicant Covidien, LLC 5920 Longbow Dr. Boulder,  CO  80301
ContactPatti L. Arndt
CorrespondentPatti L. Arndt
Covidien, LLC 5920 Longbow Dr. Boulder,  CO  80301
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-24
Decision Date2018-03-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521783928 K180192 000
10884521717411 K180192 000

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