FDA 510(k)

PIUR tUS 내부

K-번호: K250484 · 2025-06-30

결정일2025-06-30

제품 코드QIH

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

결정대체적으로 동일

기기 요약

PIUR tUS inside is the device name listed in this FDA 510(k) record. The listed applicant is Piur Imaging GmbH. It received FDA 510(k) clearance on 2025-06-30 under 510(k) number K250484. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the PIUR tUS inside?

PIUR tUS inside is a medical device that received FDA 510(k) clearance on 2025-06-30. The listed applicant is Piur Imaging GmbH. The 510(k) number is K250484.

When did PIUR tUS inside receive FDA 510(k) clearance?

PIUR tUS inside received FDA 510(k) clearance on 2025-06-30, under 510(k) number K250484.

Who is the listed applicant for PIUR tUS inside?

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

What is the FDA product code for PIUR tUS inside?

The FDA product code for PIUR tUS inside is QIH.

Piur Imaging GmbH를 신청인으로 등재한 기타 기록

K240036PIUR tUS 인피니티

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