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FDA 510(k)

CarnaLife 霍洛

K 號:K221870 · 2023-05-01

申請人Medapp S.A.
決定日期2023-05-01
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

CarnaLife Holo is the device name listed in this FDA 510(k) record. The listed applicant is Medapp S.A.. It received FDA 510(k) clearance on 2023-05-01 under 510(k) number K221870. 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 CarnaLife Holo?

CarnaLife Holo is a medical device that received FDA 510(k) clearance on 2023-05-01. The listed applicant is Medapp S.A.. The 510(k) number is K221870.

When did CarnaLife Holo receive FDA 510(k) clearance?

CarnaLife Holo received FDA 510(k) clearance on 2023-05-01, under 510(k) number K221870.

Who is the listed applicant for CarnaLife Holo?

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

What is the FDA product code for CarnaLife Holo?

The FDA product code for CarnaLife Holo is LLZ.

相關臨床試驗

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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。

官方來源

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