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 IDK162943
510k NumberK162943
Device Name:SyMRI
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant SyntheticMR AB Storgatan 11 Linkoping,  SE 582 23
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 Received2016-10-21
Decision Date2017-08-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07340024700023 K162943 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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