FDA 510(k)

量測前列腺 Prostate

K 號：K221106 · 2022-05-13

決定日期2022-05-13

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Quantib Prostate is the device name listed in this FDA 510(k) record. The listed applicant is Quantib B.V.. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K221106. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quantib Prostate?

Quantib Prostate is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Quantib B.V.. The 510(k) number is K221106.

When did Quantib Prostate receive FDA 510(k) clearance?

Quantib Prostate received FDA 510(k) clearance on 2022-05-13, under 510(k) number K221106.

Who is the listed applicant for Quantib Prostate?

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

What is the FDA product code for Quantib Prostate?

The FDA product code for Quantib Prostate is LLZ.

其他以 Quantib B.V. 為申請人之記錄

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相關器械（代碼：LLZ）

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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