MU System
K-Number: K222976 · 2023-01-12
ApplicantDentis Co., Ltd.
Decision Date2023-01-12
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
MU System is a medical device manufactured by Dentis Co., Ltd.. It received FDA 510(k) clearance on 2023-01-12 under approval number K222976. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MU System?
MU System is a medical device that received FDA 510(k) clearance on 2023-01-12. It is manufactured by Dentis Co., Ltd.. The 510(k) number is K222976.
When was MU System approved by the FDA?
MU System received FDA 510(k) clearance on 2023-01-12, under approval number K222976.
What company makes MU System?
MU System is manufactured by Dentis Co., Ltd..
What is the FDA product code for MU System?
The FDA product code for MU System is NHA.
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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.