System, Nuclear Magnetic Resonance Imaging

Nous Imaging, Inc.

The following data is part of a premarket notification filed by Nous Imaging, Inc. with the FDA for Firmm.

Pre-market Notification Details

Device IDK201141
510k NumberK201141
Device Name:FIRMM
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Nous Imaging, Inc. 4220 Duncan Ave St. Louis,  MO  63108
ContactTodd Deckard
CorrespondentRob Newman
Scion Opportunity Consulting 680 Webb Road Chadds Ford,  PA  19317
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-29
Decision Date2020-08-26

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