Epitomee
K-Number: K240544 · 2024-09-13
ApplicantEpitomee Medical , Ltd.
Decision Date2024-09-13
Product CodeQFQ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Epitomee is a medical device manufactured by Epitomee Medical , Ltd.. It received FDA 510(k) clearance on 2024-09-13 under approval number K240544. The device is classified under product code QFQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Epitomee?
Epitomee is a medical device that received FDA 510(k) clearance on 2024-09-13. It is manufactured by Epitomee Medical , Ltd.. The 510(k) number is K240544.
When was Epitomee approved by the FDA?
Epitomee received FDA 510(k) clearance on 2024-09-13, under approval number K240544.
What company makes Epitomee?
Epitomee is manufactured by Epitomee Medical , Ltd..
What is the FDA product code for Epitomee?
The FDA product code for Epitomee is QFQ.
Related Devices (Code: QFQ)
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.