MRopen EVO
K-Number: K193116 · 2019-12-20
ApplicantAsg Superconductors S.P.A.
Decision Date2019-12-20
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
MRopen EVO is a medical device manufactured by Asg Superconductors S.P.A.. It received FDA 510(k) clearance on 2019-12-20 under approval number K193116. 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 MRopen EVO?
MRopen EVO is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Asg Superconductors S.P.A.. The 510(k) number is K193116.
When was MRopen EVO approved by the FDA?
MRopen EVO received FDA 510(k) clearance on 2019-12-20, under approval number K193116.
What company makes MRopen EVO?
MRopen EVO is manufactured by Asg Superconductors S.P.A..
What is the FDA product code for MRopen EVO?
The FDA product code for MRopen EVO is LNH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.