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FDA 510(k)

ART-Plan (v.2.2.0)

K 號:K234068 · 2024-04-22

決定日期2024-04-22
產品代碼MUJ
諮詢委員會RA
決定相當於

器材摘要

ART-Plan (v.2.2.0) is the device name listed in this FDA 510(k) record. The listed applicant is Therapanacea Sas. It received FDA 510(k) clearance on 2024-04-22 under 510(k) number K234068. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ART-Plan (v.2.2.0)?

ART-Plan (v.2.2.0) is a medical device that received FDA 510(k) clearance on 2024-04-22. The listed applicant is Therapanacea Sas. The 510(k) number is K234068.

When did ART-Plan (v.2.2.0) receive FDA 510(k) clearance?

ART-Plan (v.2.2.0) received FDA 510(k) clearance on 2024-04-22, under 510(k) number K234068.

Who is the listed applicant for ART-Plan (v.2.2.0)?

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

What is the FDA product code for ART-Plan (v.2.2.0)?

The FDA product code for ART-Plan (v.2.2.0) is MUJ.

其他以 Therapanacea Sas 為申請人之記錄

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相關器械(代碼:MUJ)

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。

官方來源

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