FDA 510(k)

ART-PLAN

K 號：K220813 · 2022-06-17

決定日期2022-06-17

產品代碼QKB

諮詢委員會RA

決定相當於

器材摘要

ART-PLAN is the device name listed in this FDA 510(k) record. The listed applicant is Therapanacea. It received FDA 510(k) clearance on 2022-06-17 under 510(k) number K220813. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ART-PLAN?

ART-PLAN is a medical device that received FDA 510(k) clearance on 2022-06-17. The listed applicant is Therapanacea. The 510(k) number is K220813.

When did ART-PLAN receive FDA 510(k) clearance?

ART-PLAN received FDA 510(k) clearance on 2022-06-17, under 510(k) number K220813.

Who is the listed applicant for ART-PLAN?

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

What is the FDA product code for ART-PLAN?

The FDA product code for ART-PLAN is QKB.

其他以 Therapanacea 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。

K232479ART-Plan K202700ART-Plan

相關器械（代碼：QKB）

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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