NEURO III-SV

System, Nuclear Magnetic Resonance Imaging

IMRIS, INC.

The following data is part of a premarket notification filed by Imris, Inc. with the FDA for Neuro Iii-sv.

Pre-market Notification Details

Device IDK083137
510k NumberK083137
Device Name:NEURO III-SV
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant IMRIS, INC. 16809 BRIARDALE ROAD Rockville,  MD  20855
ContactThomas M Tsakeris
CorrespondentThomas M Tsakeris
IMRIS, INC. 16809 BRIARDALE ROAD Rockville,  MD  20855
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-23
Decision Date2008-12-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857534006202 K083137 000
00857534006196 K083137 000

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