NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM

System, Image Processing, Radiological

NICOLET BIOMEDICAL

The following data is part of a premarket notification filed by Nicolet Biomedical with the FDA for Nicolet Electromagnetic Navigation System.

Pre-market Notification Details

Device IDK013419
510k NumberK013419
Device Name:NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM
ClassificationSystem, Image Processing, Radiological
Applicant NICOLET BIOMEDICAL 6355 JOYCE DR. Golden,  CO  80403
ContactDavid W Wagner
CorrespondentDavid W Wagner
NICOLET BIOMEDICAL 6355 JOYCE DR. Golden,  CO  80403
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-15
Decision Date2001-12-20

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