FDA 510(k)

ArcCHECK-MR

K 號：K160057 · 2016-05-13

決定日期2016-05-13

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

ArcCHECK-MR is the device name listed in this FDA 510(k) record. The listed applicant is Sun Nuclear Corporation. It received FDA 510(k) clearance on 2016-05-13 under 510(k) number K160057. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ArcCHECK-MR?

ArcCHECK-MR is a medical device that received FDA 510(k) clearance on 2016-05-13. The listed applicant is Sun Nuclear Corporation. The 510(k) number is K160057.

When did ArcCHECK-MR receive FDA 510(k) clearance?

ArcCHECK-MR received FDA 510(k) clearance on 2016-05-13, under 510(k) number K160057.

Who is the listed applicant for ArcCHECK-MR?

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

What is the FDA product code for ArcCHECK-MR?

The FDA product code for ArcCHECK-MR is IYE.

其他以 Sun Nuclear Corporation 為申請人之記錄

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K170307SunCHECK K161946DoseCHECK

相關器械（代碼：IYE）

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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官方來源

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