FDA 510(k)

에테라 MX

K-번호: K171443 · 2018-04-20

신청자Vydence Medical Industria E Comercio Ltda

결정일2018-04-20

제품 코드GEX

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

결정Substantially Equivalent

기기 요약

Etherea MX is the device name listed in this FDA 510(k) record. The listed applicant is Vydence Medical Industria E Comercio Ltda. It received FDA 510(k) clearance on 2018-04-20 under 510(k) number K171443. 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 Etherea MX?

Etherea MX is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Vydence Medical Industria E Comercio Ltda. The 510(k) number is K171443.

When did Etherea MX receive FDA 510(k) clearance?

Etherea MX received FDA 510(k) clearance on 2018-04-20, under 510(k) number K171443.

Who is the listed applicant for Etherea MX?

The FDA 510(k) record lists Vydence Medical Industria E Comercio Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Etherea MX?

The FDA product code for Etherea MX is GEX. This falls under the Gastroenterology category.

Vydence Medical Industria E Comercio Ltda를 신청인으로 등재한 기타 기록

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