FDA 510(k)

卡式蒸汽滅菌器（ACA5）

K 號：K250164 · 2025-08-14

申請人Guangzhou Ajax Medical Equipment Co., Ltd.

決定日期2025-08-14

產品代碼FLE

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Cassette Autoclave (ACA5) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Ajax Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-08-14 under 510(k) number K250164. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cassette Autoclave (ACA5)?

Cassette Autoclave (ACA5) is a medical device that received FDA 510(k) clearance on 2025-08-14. The listed applicant is Guangzhou Ajax Medical Equipment Co., Ltd.. The 510(k) number is K250164.

When did Cassette Autoclave (ACA5) receive FDA 510(k) clearance?

Cassette Autoclave (ACA5) received FDA 510(k) clearance on 2025-08-14, under 510(k) number K250164.

Who is the listed applicant for Cassette Autoclave (ACA5)?

The FDA 510(k) record lists Guangzhou Ajax Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cassette Autoclave (ACA5)?

The FDA product code for Cassette Autoclave (ACA5) is FLE.

其他以 Guangzhou Ajax Medical Equipment Co., Ltd. 為申請人之記錄

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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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