EpilME
K-Number: K213261 · 2022-06-02
ApplicantNeauvia North America
Decision Date2022-06-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
EpilME is a medical device manufactured by Neauvia North America. It received FDA 510(k) clearance on 2022-06-02 under approval number K213261. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EpilME?
EpilME is a medical device that received FDA 510(k) clearance on 2022-06-02. It is manufactured by Neauvia North America. The 510(k) number is K213261.
When was EpilME approved by the FDA?
EpilME received FDA 510(k) clearance on 2022-06-02, under approval number K213261.
What company makes EpilME?
EpilME is manufactured by Neauvia North America.
What is the FDA product code for EpilME?
The FDA product code for EpilME is GEX. This falls under the Gastroenterology category.
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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.