FDA 510(k)

保護X級3等隔離衣

K 號：K211538 · 2021-11-17

決定日期2021-11-17

產品代碼FYC

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

Protect X Level 3 Isolation Gown is the device name listed in this FDA 510(k) record. The listed applicant is Azac Group. It received FDA 510(k) clearance on 2021-11-17 under 510(k) number K211538. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Protect X Level 3 Isolation Gown?

Protect X Level 3 Isolation Gown is a medical device that received FDA 510(k) clearance on 2021-11-17. The listed applicant is Azac Group. The 510(k) number is K211538.

When did Protect X Level 3 Isolation Gown receive FDA 510(k) clearance?

Protect X Level 3 Isolation Gown received FDA 510(k) clearance on 2021-11-17, under 510(k) number K211538.

Who is the listed applicant for Protect X Level 3 Isolation Gown?

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

What is the FDA product code for Protect X Level 3 Isolation Gown?

The FDA product code for Protect X Level 3 Isolation Gown is FYC.

其他以 Azac Group 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。

K242689AAMI 等級 4 保護；大褲

相關器械（代碼：FYC）

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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