EMPRINT PROCEDURE PLANNING 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 Procedure Planning Application.

Pre-market Notification Details

Device IDK142048
510k NumberK142048
Device Name:EMPRINT PROCEDURE PLANNING APPLICATION
ClassificationSystem, Image Processing, Radiological
Applicant Covidien LLC 15 HAMPSHIRE ST Mansfield,  MA  02048
ContactHeather V Nigro
CorrespondentHeather V Nigro
Covidien LLC 15 HAMPSHIRE ST Mansfield,  MA  02048
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-28
Decision Date2014-09-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521214026 K142048 000
10884521214019 K142048 000
10884521214002 K142048 000

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