SyMRI

System, Nuclear Magnetic Resonance Imaging

SyntheticMR AB

The following data is part of a premarket notification filed by Syntheticmr Ab with the FDA for Symri.

Pre-market Notification Details

Device IDK173558
510k NumberK173558
Device Name:SyMRI
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant SyntheticMR AB Storgatan 11 Linkoping,  SE 58223
ContactMaria Almesaker
CorrespondentRaymond Kelly
Licensale, Inc. 68 Southwoods Ter Southbury,  CT  06488
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-17
Decision Date2018-01-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07340024700030 K173558 000

Trademark Results [SyMRI]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYMRI
SYMRI
85974094 4661808 Live/Registered
Synthetic MR AB (publ)
2013-07-01

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