FDA 510(k)

貝爾聯診斷超音波系統

K 號：K181313 · 2018-08-27

決定日期2018-08-27

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

BenQ Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Qisda Corporation. It received FDA 510(k) clearance on 2018-08-27 under 510(k) number K181313. 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 BenQ Diagnostic Ultrasound System?

BenQ Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-08-27. The listed applicant is Qisda Corporation. The 510(k) number is K181313.

When did BenQ Diagnostic Ultrasound System receive FDA 510(k) clearance?

BenQ Diagnostic Ultrasound System received FDA 510(k) clearance on 2018-08-27, under 510(k) number K181313.

Who is the listed applicant for BenQ Diagnostic Ultrasound System?

The FDA 510(k) record lists Qisda Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BenQ Diagnostic Ultrasound System?

The FDA product code for BenQ Diagnostic Ultrasound System is IYN.

其他以 Qisda Corporation 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。

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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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