EpilME
K-Number: K213261 · 2022-06-02
Device Summary
Frequently Asked Questions
What is the EpilME?
EpilME is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is Neauvia North America. The 510(k) number is K213261.
When did EpilME receive FDA 510(k) clearance?
EpilME received FDA 510(k) clearance on 2022-06-02, under 510(k) number K213261.
Who is the listed applicant for EpilME?
The FDA 510(k) record lists Neauvia North America as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EpilME?
The FDA product code for EpilME is GEX. This falls under the Gastroenterology category.
Other records listing Neauvia North America as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: GEX)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.