FDA 510(k)

아코 아파치 울트라사운드 시스템

K-번호: K231509 · 2023-10-24

결정일2023-10-24

제품 코드IYN

자문 위원회RA

결정Substantially Equivalent

기기 요약

Aco Apache Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Aco Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2023-10-24 under 510(k) number K231509. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Aco Apache Ultrasound System?

Aco Apache Ultrasound System is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is Aco Healthcare Co., Ltd.. The 510(k) number is K231509.

When did Aco Apache Ultrasound System receive FDA 510(k) clearance?

Aco Apache Ultrasound System received FDA 510(k) clearance on 2023-10-24, under 510(k) number K231509.

Who is the listed applicant for Aco Apache Ultrasound System?

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

What is the FDA product code for Aco Apache Ultrasound System?

The FDA product code for Aco Apache Ultrasound System is IYN.

Aco Healthcare Co., Ltd.를 신청인으로 등재한 기타 기록

K211232아파치 울트라사운드 시스템

관련 기기 (코드: IYN)

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