FDA 510(k)

無線探頭型超音波掃描儀

K 號：K252709 · 2026-04-02

申請人Xuzhou Yongkang Electronic Science Technology Co., Ltd.

決定日期2026-04-02

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Wireless Probe Type Ultrasound Scanner is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Yongkang Electronic Science Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-02 under 510(k) number K252709. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Wireless Probe Type Ultrasound Scanner?

Wireless Probe Type Ultrasound Scanner is a medical device that received FDA 510(k) clearance on 2026-04-02. The listed applicant is Xuzhou Yongkang Electronic Science Technology Co., Ltd.. The 510(k) number is K252709.

When did Wireless Probe Type Ultrasound Scanner receive FDA 510(k) clearance?

Wireless Probe Type Ultrasound Scanner received FDA 510(k) clearance on 2026-04-02, under 510(k) number K252709.

Who is the listed applicant for Wireless Probe Type Ultrasound Scanner?

The FDA 510(k) record lists Xuzhou Yongkang Electronic Science Technology 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?

The FDA product code for Wireless Probe Type Ultrasound Scanner is IYN.

其他以 Xuzhou Yongkang Electronic Science Technology Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K191571紫外線治療系統 K183491手臂血壓監測器 K180314紅外線體溫計 K162616手環式血壓監測器 K161938指尖血氧計

相關器械（代碼：IYN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。