Biofourmis Everion+ (G2)
K-Number: K233418 · 2024-05-09
ApplicantBiofourmis Singapore Pte., Ltd.
Decision Date2024-05-09
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Biofourmis Everion+ (G2) is a medical device manufactured by Biofourmis Singapore Pte., Ltd.. It received FDA 510(k) clearance on 2024-05-09 under approval number K233418. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Biofourmis Everion+ (G2)?
Biofourmis Everion+ (G2) is a medical device that received FDA 510(k) clearance on 2024-05-09. It is manufactured by Biofourmis Singapore Pte., Ltd.. The 510(k) number is K233418.
When was Biofourmis Everion+ (G2) approved by the FDA?
Biofourmis Everion+ (G2) received FDA 510(k) clearance on 2024-05-09, under approval number K233418.
What company makes Biofourmis Everion+ (G2)?
Biofourmis Everion+ (G2) is manufactured by Biofourmis Singapore Pte., Ltd..
What is the FDA product code for Biofourmis Everion+ (G2)?
The FDA product code for Biofourmis Everion+ (G2) is MSX.
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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.