Emprint 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 Visualization Application.

Pre-market Notification Details

Device IDK192038
510k NumberK192038
Device Name:Emprint Visualization Application
ClassificationSystem, Image Processing, Radiological
Applicant Covidien LLC. 5920 Longbow Drive Boulder,  CO  80301
ContactJanna Babson
CorrespondentTim Thomas
Covidien LLC 6135 Gunbarrel Avenue Boulder,  CO  80301
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-30
Decision Date2019-12-02

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