FDA 510(k)

便携式数字彩色多普勒超声系统（SCN201D，SCN201L）

K号: K241554 · 2024-10-24

申请人Telefield Medical Imaging (Shenzhen) Limited

决定日期2024-10-24

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) is the device name listed in this FDA 510(k) record. The listed applicant is Telefield Medical Imaging (Shenzhen) Limited. It received FDA 510(k) clearance on 2024-10-24 under 510(k) number K241554. 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 Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)?

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) is a medical device that received FDA 510(k) clearance on 2024-10-24. The listed applicant is Telefield Medical Imaging (Shenzhen) Limited. The 510(k) number is K241554.

When did Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) receive FDA 510(k) clearance?

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) received FDA 510(k) clearance on 2024-10-24, under 510(k) number K241554.

Who is the listed applicant for Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)?

The FDA 510(k) record lists Telefield Medical Imaging (Shenzhen) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)?

The FDA product code for Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) is IYN.

相关器械（代码：IYN）

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器械摘要

常见问题

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相关器械（代码：IYN）

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