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FDA 510(k)

外科3D口罩

K 號：K203565 · 2021-10-19

申請人Inno Lifecare
決定日期2021-10-19
產品代碼FXX
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

Surgical 3D Mask is the device name listed in this FDA 510(k) record. The listed applicant is Inno Lifecare. It received FDA 510(k) clearance on 2021-10-19 under 510(k) number K203565. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Surgical 3D Mask?

Surgical 3D Mask is a medical device that received FDA 510(k) clearance on 2021-10-19. The listed applicant is Inno Lifecare. The 510(k) number is K203565.

When did Surgical 3D Mask receive FDA 510(k) clearance?

Surgical 3D Mask received FDA 510(k) clearance on 2021-10-19, under 510(k) number K203565.

Who is the listed applicant for Surgical 3D Mask?

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

What is the FDA product code for Surgical 3D Mask?

The FDA product code for Surgical 3D Mask is FXX.

相關臨床試驗

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相關器械（代碼：FXX）

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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