FDA 510(k)

信標標記

K 號：K211590 · 2021-06-10

決定日期2021-06-10

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

Fiducial Marker is the device name listed in this FDA 510(k) record. The listed applicant is Carbon Medical Technologies, Inc.. It received FDA 510(k) clearance on 2021-06-10 under 510(k) number K211590. 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 Fiducial Marker?

Fiducial Marker is a medical device that received FDA 510(k) clearance on 2021-06-10. The listed applicant is Carbon Medical Technologies, Inc.. The 510(k) number is K211590.

When did Fiducial Marker receive FDA 510(k) clearance?

Fiducial Marker received FDA 510(k) clearance on 2021-06-10, under 510(k) number K211590.

Who is the listed applicant for Fiducial Marker?

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

What is the FDA product code for Fiducial Marker?

The FDA product code for Fiducial Marker is IYE.

其他以 Carbon Medical Technologies, Inc. 為申請人之記錄

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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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