FDA 510(k)

AFS 의료 소독 단일 사용 접근 포트 시스템

K-번호: K202688 · 2021-10-14

결정일2021-10-14

제품 코드OTJ

자문 위원회GU

결정Substantially Equivalent

기기 요약

AFS Medical Sterile Single-Use Access Port System is the device name listed in this FDA 510(k) record. The listed applicant is Afs Medical Co. , Ltd.. It received FDA 510(k) clearance on 2021-10-14 under 510(k) number K202688. The device is classified under product code OTJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the AFS Medical Sterile Single-Use Access Port System?

AFS Medical Sterile Single-Use Access Port System is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is Afs Medical Co. , Ltd.. The 510(k) number is K202688.

When did AFS Medical Sterile Single-Use Access Port System receive FDA 510(k) clearance?

AFS Medical Sterile Single-Use Access Port System received FDA 510(k) clearance on 2021-10-14, under 510(k) number K202688.

Who is the listed applicant for AFS Medical Sterile Single-Use Access Port System?

The FDA 510(k) record lists Afs Medical Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFS Medical Sterile Single-Use Access Port System?

The FDA product code for AFS Medical Sterile Single-Use Access Port System is OTJ.

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AFS 의료 소독 단일 사용 접근 포트 시스템

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: OTJ)

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