NICOLET PIONEER TC8080

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 Pioneer Tc8080.

Pre-market Notification Details

Device IDK020754
510k NumberK020754
Device Name:NICOLET PIONEER TC8080
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant NICOLET BIOMEDICAL 800 LEVANGER LN. Stoughton,  WI  53589
ContactGary Syring
CorrespondentGary Syring
NICOLET BIOMEDICAL 800 LEVANGER LN. Stoughton,  WI  53589
Product CodeIYN  
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-07
Decision Date2003-04-21

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