FDA 510(k)

AAMI 等級 4 保護；大褲

K 號：K242689 · 2025-01-13

決定日期2025-01-13

產品代碼QPC

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

AAMI Level 4 Protective; 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 2025-01-13 under 510(k) number K242689. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AAMI Level 4 Protective; Gown?

AAMI Level 4 Protective; Gown is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Azac Group. The 510(k) number is K242689.

When did AAMI Level 4 Protective; Gown receive FDA 510(k) clearance?

AAMI Level 4 Protective; Gown received FDA 510(k) clearance on 2025-01-13, under 510(k) number K242689.

Who is the listed applicant for AAMI Level 4 Protective; 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 AAMI Level 4 Protective; Gown?

The FDA product code for AAMI Level 4 Protective; Gown is QPC.

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。

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相關器械（代碼：QPC）

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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