SPIN-SWI

System, Nuclear Magnetic Resonance Imaging

SpinTech, Inc.

The following data is part of a premarket notification filed by Spintech, Inc. with the FDA for Spin-swi.

Pre-market Notification Details

Device IDK173224
510k NumberK173224
Device Name:SPIN-SWI
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant SpinTech, Inc. 30200 Telegraph Road Suite 140 Bingham Farms,  MI  48025
ContactKay Fuller
CorrespondentKay Fuller
SpinTech, Inc. 30200 Telegraph Road Suite 140 Bingham Farms,  MI  48025
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-03
Decision Date2018-02-23
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.