FDA 510(k)

口袋式超声系统（C10，C10TX，C10RL，C10RLpro）

K号: K241979 · 2024-08-22

申请人Beijing Konted Medical Technology Co.,Ltd

决定日期2024-08-22

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Konted Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K241979. 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 Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)?

Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Beijing Konted Medical Technology Co.,Ltd. The 510(k) number is K241979.

When did Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) receive FDA 510(k) clearance?

Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) received FDA 510(k) clearance on 2024-08-22, under 510(k) number K241979.

Who is the listed applicant for Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)?

FDA 510(k)记录显示北京康特医疗科技有限公司为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)?

The FDA product code for Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) is IYN.

列明Beijing Konted Medical Technology 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。

K261081口袋式超声系统（C10MTpro，C10MXpro，C10MSpro，C10MBpro，C10MRpro）K231354口袋超声系统（C10）

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

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