FDA 510(k)

CRUXVIEW

K 號：K211317 · 2021-07-29

決定日期2021-07-29

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

CRUXVIEW is the device name listed in this FDA 510(k) record. The listed applicant is Cruxell Corp.. It received FDA 510(k) clearance on 2021-07-29 under 510(k) number K211317. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CRUXVIEW?

CRUXVIEW is a medical device that received FDA 510(k) clearance on 2021-07-29. The listed applicant is Cruxell Corp.. The 510(k) number is K211317.

When did CRUXVIEW receive FDA 510(k) clearance?

CRUXVIEW received FDA 510(k) clearance on 2021-07-29, under 510(k) number K211317.

Who is the listed applicant for CRUXVIEW?

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

What is the FDA product code for CRUXVIEW?

The FDA product code for CRUXVIEW is MUH.

其他以 Cruxell Corp. 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。

K183637Cruxcan (CRX-1000)

相關器械（代碼：MUH）

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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