FDA 510(k)

无线探头式超声扫描仪（型号：CProbe；类型：C型、L型、CT型、CL型）

K号: K211321 · 2022-10-13

申请人Guangzhou Sonostar Technologies Co., Ltd.

决定日期2022-10-13

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) 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 2022-10-13 under 510(k) number K211321. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)?

Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) is a medical device that received FDA 510(k) clearance on 2022-10-13. The listed applicant is Guangzhou Sonostar Technologies Co., Ltd.. The 510(k) number is K211321.

When did Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) receive FDA 510(k) clearance?

Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) received FDA 510(k) clearance on 2022-10-13, under 510(k) number K211321.

Who is the listed applicant for Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)?

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 Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)?

The FDA product code for Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) is IYN.

列明Guangzhou Sonostar Technologies Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K172750无线探头式超声扫描仪（型号：UProbe-C；UProbe-L；BProbe）K171926C5 诊断超声系统

相关器械（代码：IYN）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。