FDA 510(k)

InnoVoyce VYLO

K番号: K240159 · 2024-05-29

決定日2024-05-29

製品コードGEX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

InnoVoyce VYLO is the device name listed in this FDA 510(k) record. The listed applicant is Innovoyce. It received FDA 510(k) clearance on 2024-05-29 under 510(k) number K240159. 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.

よくある質問

What is the InnoVoyce VYLO?

InnoVoyce VYLO is a medical device that received FDA 510(k) clearance on 2024-05-29. The listed applicant is Innovoyce. The 510(k) number is K240159.

When did InnoVoyce VYLO receive FDA 510(k) clearance?

InnoVoyce VYLO received FDA 510(k) clearance on 2024-05-29, under 510(k) number K240159.

Who is the listed applicant for InnoVoyce VYLO?

The FDA 510(k) record lists Innovoyce as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InnoVoyce VYLO?

The FDA product code for InnoVoyce VYLO is GEX. This falls under the Gastroenterology category.

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InnoVoyce VYLO

医療機器の概要

よくある質問

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