FDA 510(k)

Paneffort 3層外科及手術口罩

K 號：K221409 · 2022-07-25

決定日期2022-07-25

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

Paneffort 3-ply Surgical and Procedural Masks is the device name listed in this FDA 510(k) record. The listed applicant is Paneffort, LLC. It received FDA 510(k) clearance on 2022-07-25 under 510(k) number K221409. 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 Paneffort 3-ply Surgical and Procedural Masks?

Paneffort 3-ply Surgical and Procedural Masks is a medical device that received FDA 510(k) clearance on 2022-07-25. The listed applicant is Paneffort, LLC. The 510(k) number is K221409.

When did Paneffort 3-ply Surgical and Procedural Masks receive FDA 510(k) clearance?

Paneffort 3-ply Surgical and Procedural Masks received FDA 510(k) clearance on 2022-07-25, under 510(k) number K221409.

Who is the listed applicant for Paneffort 3-ply Surgical and Procedural Masks?

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

What is the FDA product code for Paneffort 3-ply Surgical and Procedural Masks?

The FDA product code for Paneffort 3-ply Surgical and Procedural Masks is FXX.

其他以 Paneffort, LLC 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。

K212717Paneffort AAMI等級3隔離袍

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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