FDA 510(k)

encevis (2.1)

K-번호: K240993 · 2024-09-27

신청자Ait Austrian Institute of Technology GmbH

결정일2024-09-27

제품 코드OMB

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

결정Substantially Equivalent

기기 요약

encevis (2.1) is the device name listed in this FDA 510(k) record. The listed applicant is Ait Austrian Institute of Technology GmbH. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K240993. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the encevis (2.1)?

encevis (2.1) is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Ait Austrian Institute of Technology GmbH. The 510(k) number is K240993.

When did encevis (2.1) receive FDA 510(k) clearance?

encevis (2.1) received FDA 510(k) clearance on 2024-09-27, under 510(k) number K240993.

Who is the listed applicant for encevis (2.1)?

The FDA 510(k) record lists Ait Austrian Institute of Technology GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for encevis (2.1)?

The FDA product code for encevis (2.1) is OMB.

Ait Austrian Institute of Technology GmbH를 신청인으로 등재한 기타 기록

K171720encevis

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