Magicore II System
K-Number: K192197 · 2020-04-28
ApplicantInnobiosurg Co., Ltd.
Decision Date2020-04-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Magicore II System is a medical device manufactured by Innobiosurg Co., Ltd.. It received FDA 510(k) clearance on 2020-04-28 under approval number K192197. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Magicore II System?
Magicore II System is a medical device that received FDA 510(k) clearance on 2020-04-28. It is manufactured by Innobiosurg Co., Ltd.. The 510(k) number is K192197.
When was Magicore II System approved by the FDA?
Magicore II System received FDA 510(k) clearance on 2020-04-28, under approval number K192197.
What company makes Magicore II System?
Magicore II System is manufactured by Innobiosurg Co., Ltd..
What is the FDA product code for Magicore II System?
The FDA product code for Magicore II System is DZE.
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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.