REXSIN
K-Number: K200392 · 2020-07-07
ApplicantSm Eng Co., Ltd.
Decision Date2020-07-07
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
REXSIN is a medical device manufactured by Sm Eng Co., Ltd.. It received FDA 510(k) clearance on 2020-07-07 under approval number K200392. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the REXSIN?
REXSIN is a medical device that received FDA 510(k) clearance on 2020-07-07. It is manufactured by Sm Eng Co., Ltd.. The 510(k) number is K200392.
When was REXSIN approved by the FDA?
REXSIN received FDA 510(k) clearance on 2020-07-07, under approval number K200392.
What company makes REXSIN?
REXSIN is manufactured by Sm Eng Co., Ltd..
What is the FDA product code for REXSIN?
The FDA product code for REXSIN is GAM.
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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.