FDA 510(k)

라이프엔도; 라이프엔도 2.0

K-번호: K241771 · 2024-09-16

신청자Medical San Indústria DE Equipamentos Médicos Ltda.

결정일2024-09-16

제품 코드GEX

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

결정대체적으로 동일

기기 요약

Liftendo; Liftendo 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Medical San Indústria DE Equipamentos Médicos Ltda.. It received FDA 510(k) clearance on 2024-09-16 under 510(k) number K241771. 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 Liftendo; Liftendo 2.0?

Liftendo; Liftendo 2.0 is a medical device that received FDA 510(k) clearance on 2024-09-16. The listed applicant is Medical San Indústria DE Equipamentos Médicos Ltda.. The 510(k) number is K241771.

When did Liftendo; Liftendo 2.0 receive FDA 510(k) clearance?

Liftendo; Liftendo 2.0 received FDA 510(k) clearance on 2024-09-16, under 510(k) number K241771.

Who is the listed applicant for Liftendo; Liftendo 2.0?

The FDA 510(k) record lists Medical San Indústria DE Equipamentos Médicos Ltda. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Liftendo; Liftendo 2.0?

The FDA product code for Liftendo; Liftendo 2.0 is GEX. This falls under the Gastroenterology category.

Medical San Indústria DE Equipamentos Médicos Ltda.를 신청인으로 등재한 기타 기록

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