FDA 510(k)

藍幻影PT

K 號：K191821 · 2020-01-23

決定日期2020-01-23

產品代碼LHN

諮詢委員會RA

決定相當於

器材摘要

Blue Phantom PT is the device name listed in this FDA 510(k) record. The listed applicant is Iba Dosimetry GmbH. It received FDA 510(k) clearance on 2020-01-23 under 510(k) number K191821. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Blue Phantom PT?

Blue Phantom PT is a medical device that received FDA 510(k) clearance on 2020-01-23. The listed applicant is Iba Dosimetry GmbH. The 510(k) number is K191821.

When did Blue Phantom PT receive FDA 510(k) clearance?

Blue Phantom PT received FDA 510(k) clearance on 2020-01-23, under 510(k) number K191821.

Who is the listed applicant for Blue Phantom PT?

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

What is the FDA product code for Blue Phantom PT?

The FDA product code for Blue Phantom PT is LHN.

其他以 Iba Dosimetry GmbH 為申請人之記錄

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K201798我的QA iON

相關器械（代碼：LHN）

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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