FDA 510(k)

我的飛龍外科口罩第3級

K 號：K212111 · 2022-01-23

申請人Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi

決定日期2022-01-23

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

Myflon Surgical Mask Level 3 is the device name listed in this FDA 510(k) record. The listed applicant is Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi. It received FDA 510(k) clearance on 2022-01-23 under 510(k) number K212111. 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 Myflon Surgical Mask Level 3?

Myflon Surgical Mask Level 3 is a medical device that received FDA 510(k) clearance on 2022-01-23. The listed applicant is Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi. The 510(k) number is K212111.

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

Myflon Surgical Mask Level 3 received FDA 510(k) clearance on 2022-01-23, under 510(k) number K212111.

Who is the listed applicant for Myflon Surgical Mask Level 3?

The FDA 510(k) record lists Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Myflon Surgical Mask Level 3?

The FDA product code for Myflon Surgical Mask Level 3 is FXX.

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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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