LX9max
K-Number: K203498 · 2021-07-02
ApplicantDaesung Maref Co., Ltd.
Decision Date2021-07-02
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
LX9max is a medical device manufactured by Daesung Maref Co., Ltd.. It received FDA 510(k) clearance on 2021-07-02 under approval number K203498. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LX9max?
LX9max is a medical device that received FDA 510(k) clearance on 2021-07-02. It is manufactured by Daesung Maref Co., Ltd.. The 510(k) number is K203498.
When was LX9max approved by the FDA?
LX9max received FDA 510(k) clearance on 2021-07-02, under approval number K203498.
What company makes LX9max?
LX9max is manufactured by Daesung Maref Co., Ltd..
What is the FDA product code for LX9max?
The FDA product code for LX9max is IRP.
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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.