FDA 510(k)

아벤다 헬스 트리트먼트 시스템

K-번호: K201687 · 2020-11-30

결정일2020-11-30

제품 코드GEX

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Avenda Health Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is Avenda Health, Inc.. It received FDA 510(k) clearance on 2020-11-30 under 510(k) number K201687. 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.

자주 묻는 질문

What is the Avenda Health Treatment System?

Avenda Health Treatment System is a medical device that received FDA 510(k) clearance on 2020-11-30. The listed applicant is Avenda Health, Inc.. The 510(k) number is K201687.

When did Avenda Health Treatment System receive FDA 510(k) clearance?

Avenda Health Treatment System received FDA 510(k) clearance on 2020-11-30, under 510(k) number K201687.

Who is the listed applicant for Avenda Health Treatment System?

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

What is the FDA product code for Avenda Health Treatment System?

The FDA product code for Avenda Health Treatment System is GEX. This falls under the Gastroenterology category.

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