INSTRUMENTARIUM MEGA4 HT

System, Nuclear Magnetic Resonance Imaging

INSTRUMENTARIUM IMAGING, INC.

The following data is part of a premarket notification filed by Instrumentarium Imaging, Inc. with the FDA for Instrumentarium Mega4 Ht.

Pre-market Notification Details

Device IDK923352
510k NumberK923352
Device Name:INSTRUMENTARIUM MEGA4 HT
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee,  WI  53207 -6025
ContactRichard E Halbach
CorrespondentRichard E Halbach
INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee,  WI  53207 -6025
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-08
Decision Date1992-10-06

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