REXMONO, PDREX
K-Number: K173779 · 2018-03-12
ApplicantSm Eng Co., Ltd.
Decision Date2018-03-12
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
REXMONO, PDREX is a medical device manufactured by Sm Eng Co., Ltd.. It received FDA 510(k) clearance on 2018-03-12 under approval number K173779. 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 REXMONO, PDREX?
REXMONO, PDREX is a medical device that received FDA 510(k) clearance on 2018-03-12. It is manufactured by Sm Eng Co., Ltd.. The 510(k) number is K173779.
When was REXMONO, PDREX approved by the FDA?
REXMONO, PDREX received FDA 510(k) clearance on 2018-03-12, under approval number K173779.
What company makes REXMONO, PDREX?
REXMONO, PDREX is manufactured by Sm Eng Co., Ltd..
What is the FDA product code for REXMONO, PDREX?
The FDA product code for REXMONO, PDREX 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.