NICOLET EME LEGEND TC22

System, Imaging, Pulsed Doppler, Ultrasonic

NICOLET BIOMEDICAL

The following data is part of a premarket notification filed by Nicolet Biomedical with the FDA for Nicolet Eme Legend Tc22.

Pre-market Notification Details

Device IDK993939
510k NumberK993939
Device Name:NICOLET EME LEGEND TC22
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant NICOLET BIOMEDICAL 6355 JOYCE DR. Golden,  CO  80403
ContactDavid W Wagner
CorrespondentDavid W Wagner
NICOLET BIOMEDICAL 6355 JOYCE DR. Golden,  CO  80403
Product CodeIYN  
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-19
Decision Date2000-06-29

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