SyMRI
K-Number: K191036 · 2019-06-13
ApplicantSyntheticmr AB
Decision Date2019-06-13
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SyMRI is a medical device manufactured by Syntheticmr AB. It received FDA 510(k) clearance on 2019-06-13 under approval number K191036. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SyMRI?
SyMRI is a medical device that received FDA 510(k) clearance on 2019-06-13. It is manufactured by Syntheticmr AB. The 510(k) number is K191036.
When was SyMRI approved by the FDA?
SyMRI received FDA 510(k) clearance on 2019-06-13, under approval number K191036.
What company makes SyMRI?
SyMRI is manufactured by Syntheticmr AB.
What is the FDA product code for SyMRI?
The FDA product code for SyMRI is LNH.
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Official Source
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