ST SENSE NV 8 ARRAY COIL

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 St Sense Nv 8 Array Coil.

Pre-market Notification Details

Device IDK140282
510k NumberK140282
Device Name:ST SENSE NV 8 ARRAY COIL
ClassificationCoil, Magnetic Resonance, Specialty
Applicant RESONANCE INNOVATIONS LLC 9840 S 140th St Ste 8 Omaha,  NE  68138
ContactRandall Jones
CorrespondentRandall Jones
RESONANCE INNOVATIONS LLC 9840 S 140th St Ste 8 Omaha,  NE  68138
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-04
Decision Date2014-02-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00859193006326 K140282 000

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