FDA 510(k)

Acuson SC2000 診斷超聲波系統

K 號：K171766 · 2017-07-12

決定日期2017-07-12

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

Acuson SC2000 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2017-07-12 under 510(k) number K171766. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Acuson SC2000 Diagnostic Ultrasound System?

Acuson SC2000 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-07-12. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K171766.

When did Acuson SC2000 Diagnostic Ultrasound System receive FDA 510(k) clearance?

Acuson SC2000 Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-07-12, under 510(k) number K171766.

Who is the listed applicant for Acuson SC2000 Diagnostic Ultrasound System?

The FDA 510(k) record lists Siemens Medi Cal Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acuson SC2000 Diagnostic Ultrasound System?

The FDA product code for Acuson SC2000 Diagnostic Ultrasound System is IYO.

其他以 Siemens Medi Cal Solutions, Inc. 為申請人之記錄

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相關器械（代碼：IYO）

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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