FDA 510(k)

C5 Diagnostic Ultrasound System

K-번호: K171926 · 2017-10-27

신청자Guangzhou Sonostar Technologies Co., Ltd.

결정일2017-10-27

제품 코드IYN

자문 위원회RA

결정Substantially Equivalent

기기 요약

C5 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Sonostar Technologies Co., Ltd.. It received FDA 510(k) clearance on 2017-10-27 under 510(k) number K171926. 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 C5 Diagnostic Ultrasound System?

C5 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-10-27. The listed applicant is Guangzhou Sonostar Technologies Co., Ltd.. The 510(k) number is K171926.

When did C5 Diagnostic Ultrasound System receive FDA 510(k) clearance?

C5 Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-10-27, under 510(k) number K171926.

Who is the listed applicant for C5 Diagnostic Ultrasound System?

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

What is the FDA product code for C5 Diagnostic Ultrasound System?

The FDA product code for C5 Diagnostic Ultrasound System is IYN.

Guangzhou Sonostar Technologies Co., Ltd.를 신청인으로 등재한 기타 기록

K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)

관련 기기 (코드: IYN)

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