FDA 510(k)

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K 號：K173801 · 2018-07-11

申請人Shenzhen Delica Medical Equipment Co., Ltd.

決定日期2018-07-11

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Transcranial Doppler Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Delica Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2018-07-11 under 510(k) number K173801. 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 Transcranial Doppler Ultrasound System?

Transcranial Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-07-11. The listed applicant is Shenzhen Delica Medical Equipment Co., Ltd.. The 510(k) number is K173801.

When did Transcranial Doppler Ultrasound System receive FDA 510(k) clearance?

Transcranial Doppler Ultrasound System received FDA 510(k) clearance on 2018-07-11, under 510(k) number K173801.

Who is the listed applicant for Transcranial Doppler Ultrasound System?

The FDA 510(k) record lists Shenzhen Delica Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transcranial Doppler Ultrasound System?

The FDA product code for Transcranial Doppler Ultrasound System is IYN.

其他以 Shenzhen Delica Medical Equipment Co., Ltd. 為申請人之記錄

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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

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