FDA 510(k)

DEKA 모투스 AX

K-번호: K162886 · 2017-06-19

결정일2017-06-19

제품 코드GEX

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

결정대체적으로 동일

기기 요약

DEKA MOTUS AX is the device name listed in this FDA 510(k) record. The listed applicant is El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2017-06-19 under 510(k) number K162886. 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 DEKA MOTUS AX?

DEKA MOTUS AX is a medical device that received FDA 510(k) clearance on 2017-06-19. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K162886.

When did DEKA MOTUS AX receive FDA 510(k) clearance?

DEKA MOTUS AX received FDA 510(k) clearance on 2017-06-19, under 510(k) number K162886.

Who is the listed applicant for DEKA MOTUS AX?

The FDA 510(k) record lists El.En Electronic Engineering Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEKA MOTUS AX?

The FDA product code for DEKA MOTUS AX is GEX. This falls under the Gastroenterology category.

El.En Electronic Engineering Spa를 신청인으로 등재한 기타 기록

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