3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000

Coil, Magnetic Resonance, Specialty

RESONANCE INNOVATIONS LLC

The following data is part of a premarket notification filed by Resonance Innovations Llc with the FDA for 3.0t Pediatric Head And Spine Array, Model 808ge3000.

Pre-market Notification Details

Device IDK061170
510k NumberK061170
Device Name:3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000
ClassificationCoil, Magnetic Resonance, Specialty
Applicant RESONANCE INNOVATIONS LLC 12530 HARNEY CIRCLE Omaha,  NE  68154
ContactRandall Jones
CorrespondentRandall Jones
RESONANCE INNOVATIONS LLC 12530 HARNEY CIRCLE Omaha,  NE  68154
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-27
Decision Date2006-05-25
Summary:summary

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