FDA 510(k)

ACUSON S3000, S2000 診斷超音波系統

K 號：K183575 · 2019-03-20

決定日期2019-03-20

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

ACUSON S3000, S2000 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthineers. It received FDA 510(k) clearance on 2019-03-20 under 510(k) number K183575. 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 ACUSON S3000, S2000 Diagnostic Ultrasound System?

ACUSON S3000, S2000 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-03-20. The listed applicant is Siemens Healthineers. The 510(k) number is K183575.

When did ACUSON S3000, S2000 Diagnostic Ultrasound System receive FDA 510(k) clearance?

ACUSON S3000, S2000 Diagnostic Ultrasound System received FDA 510(k) clearance on 2019-03-20, under 510(k) number K183575.

Who is the listed applicant for ACUSON S3000, S2000 Diagnostic Ultrasound System?

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

What is the FDA product code for ACUSON S3000, S2000 Diagnostic Ultrasound System?

The FDA product code for ACUSON S3000, S2000 Diagnostic Ultrasound System is IYN.

其他以 Siemens Healthineers 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。

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