FDA 510(k)

SIR-Spheres 微膠球活性計算器 (SMAC)

K 號：K202392 · 2020-10-23

決定日期2020-10-23

產品代碼KPS

諮詢委員會RA

決定相當於

器材摘要

SIR-Spheres Microspheres Activity Calculator (SMAC) is the device name listed in this FDA 510(k) record. The listed applicant is Sirtex Medical US Holdings, Inc.. It received FDA 510(k) clearance on 2020-10-23 under 510(k) number K202392. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SIR-Spheres Microspheres Activity Calculator (SMAC)?

SIR-Spheres Microspheres Activity Calculator (SMAC) is a medical device that received FDA 510(k) clearance on 2020-10-23. The listed applicant is Sirtex Medical US Holdings, Inc.. The 510(k) number is K202392.

When did SIR-Spheres Microspheres Activity Calculator (SMAC) receive FDA 510(k) clearance?

SIR-Spheres Microspheres Activity Calculator (SMAC) received FDA 510(k) clearance on 2020-10-23, under 510(k) number K202392.

Who is the listed applicant for SIR-Spheres Microspheres Activity Calculator (SMAC)?

The FDA 510(k) record lists Sirtex Medical US Holdings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIR-Spheres Microspheres Activity Calculator (SMAC)?

The FDA product code for SIR-Spheres Microspheres Activity Calculator (SMAC) is KPS.

相關器械（代碼：KPS）

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。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：KPS）

官方來源