Resoundant Acoustic Driver System

System, Nuclear Magnetic Resonance Imaging

Resoundant Inc

The following data is part of a premarket notification filed by Resoundant Inc with the FDA for Resoundant Acoustic Driver System.

Pre-market Notification Details

Device IDK201389
510k NumberK201389
Device Name:Resoundant Acoustic Driver System
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Resoundant Inc 421 First Ave SW Suite 204W Rochester,  MN  55902
ContactJohn Hartigan
CorrespondentJohn Hartigan
Resoundant Inc 421 First Ave SW Suite 204W Rochester,  MN  55902
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-27
Decision Date2020-07-10

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