FDA 510(k)

Paneffort AAMI 레벨 3 이소레이션 드레스

K-번호: K212717 · 2022-11-30

결정일2022-11-30

제품 코드FYC

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

결정대체적으로 동일

기기 요약

Paneffort AAMI Level 3 Isolation Gown is the device name listed in this FDA 510(k) record. The listed applicant is Paneffort, LLC. It received FDA 510(k) clearance on 2022-11-30 under 510(k) number K212717. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Paneffort AAMI Level 3 Isolation Gown?

Paneffort AAMI Level 3 Isolation Gown is a medical device that received FDA 510(k) clearance on 2022-11-30. The listed applicant is Paneffort, LLC. The 510(k) number is K212717.

When did Paneffort AAMI Level 3 Isolation Gown receive FDA 510(k) clearance?

Paneffort AAMI Level 3 Isolation Gown received FDA 510(k) clearance on 2022-11-30, under 510(k) number K212717.

Who is the listed applicant for Paneffort AAMI Level 3 Isolation Gown?

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

What is the FDA product code for Paneffort AAMI Level 3 Isolation Gown?

The FDA product code for Paneffort AAMI Level 3 Isolation Gown is FYC.

Paneffort, LLC를 신청인으로 등재한 기타 기록

K221409Paneffort 3층 수술 및 절차 마스크

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