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FDA 510(k)

MAF 監護器

K 號：K211487 · 2021-12-08

申請人Maf Clothing Pvt Ltd Unit-3
決定日期2021-12-08
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

MAF Guard is the device name listed in this FDA 510(k) record. The listed applicant is Maf Clothing Pvt Ltd Unit-3. It received FDA 510(k) clearance on 2021-12-08 under 510(k) number K211487. 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 MAF Guard?

MAF Guard is a medical device that received FDA 510(k) clearance on 2021-12-08. The listed applicant is Maf Clothing Pvt Ltd Unit-3. The 510(k) number is K211487.

When did MAF Guard receive FDA 510(k) clearance?

MAF Guard received FDA 510(k) clearance on 2021-12-08, under 510(k) number K211487.

Who is the listed applicant for MAF Guard?

The FDA 510(k) record lists Maf Clothing Pvt Ltd Unit-3 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAF Guard?

The FDA product code for MAF Guard 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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