FDA 510(k)

용기성 주사針 가이드 및 그리드

K-번호: K223689 · 2023-08-02

결정일2023-08-02

제품 코드ITX

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

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기기 요약

Disposable Needle Guides and Grids is the device name listed in this FDA 510(k) record. The listed applicant is Advance Medical Designs, Inc.. It received FDA 510(k) clearance on 2023-08-02 under 510(k) number K223689. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Disposable Needle Guides and Grids?

Disposable Needle Guides and Grids is a medical device that received FDA 510(k) clearance on 2023-08-02. The listed applicant is Advance Medical Designs, Inc.. The 510(k) number is K223689.

When did Disposable Needle Guides and Grids receive FDA 510(k) clearance?

Disposable Needle Guides and Grids received FDA 510(k) clearance on 2023-08-02, under 510(k) number K223689.

Who is the listed applicant for Disposable Needle Guides and Grids?

The FDA 510(k) record lists Advance Medical Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Needle Guides and Grids?

The FDA product code for Disposable Needle Guides and Grids is ITX.

Advance Medical Designs, Inc.를 신청인으로 등재한 기타 기록

K163050Advance Medical Designs, Inc. 소독된 울트라사운드 젤

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