Everion+ System
K-Number: K213863 · 2023-02-23
ApplicantBiofourmis Singapore Pte., Ltd.
Decision Date2023-02-23
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Everion+ System is a medical device manufactured by Biofourmis Singapore Pte., Ltd.. It received FDA 510(k) clearance on 2023-02-23 under approval number K213863. 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 Everion+ System?
Everion+ System is a medical device that received FDA 510(k) clearance on 2023-02-23. It is manufactured by Biofourmis Singapore Pte., Ltd.. The 510(k) number is K213863.
When was Everion+ System approved by the FDA?
Everion+ System received FDA 510(k) clearance on 2023-02-23, under approval number K213863.
What company makes Everion+ System?
Everion+ System is manufactured by Biofourmis Singapore Pte., Ltd..
What is the FDA product code for Everion+ System?
The FDA product code for Everion+ System 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.