FDA 510(k)

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K-번호: K241656 · 2024-08-12

결정일2024-08-12

제품 코드GEX

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

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기기 요약

Eneka Selectif is the device name listed in this FDA 510(k) record. The listed applicant is Termosalud. It received FDA 510(k) clearance on 2024-08-12 under 510(k) number K241656. 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 Eneka Selectif?

Eneka Selectif is a medical device that received FDA 510(k) clearance on 2024-08-12. The listed applicant is Termosalud. The 510(k) number is K241656.

When did Eneka Selectif receive FDA 510(k) clearance?

Eneka Selectif received FDA 510(k) clearance on 2024-08-12, under 510(k) number K241656.

Who is the listed applicant for Eneka Selectif?

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

What is the FDA product code for Eneka Selectif?

The FDA product code for Eneka Selectif is GEX. This falls under the Gastroenterology category.

Termosalud를 신청인으로 등재한 기타 기록

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