FDA 510(k)

A-TAP（以前稱為Arthrotap）

K 號：K231900 · 2023-07-25

決定日期2023-07-25

產品代碼FMF

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

A-TAP (previously called Arthrotap) is the device name listed in this FDA 510(k) record. The listed applicant is Elcam Medical Acal. It received FDA 510(k) clearance on 2023-07-25 under 510(k) number K231900. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the A-TAP (previously called Arthrotap)?

A-TAP (previously called Arthrotap) is a medical device that received FDA 510(k) clearance on 2023-07-25. The listed applicant is Elcam Medical Acal. The 510(k) number is K231900.

When did A-TAP (previously called Arthrotap) receive FDA 510(k) clearance?

A-TAP (previously called Arthrotap) received FDA 510(k) clearance on 2023-07-25, under 510(k) number K231900.

Who is the listed applicant for A-TAP (previously called Arthrotap)?

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

What is the FDA product code for A-TAP (previously called Arthrotap)?

The FDA product code for A-TAP (previously called Arthrotap) is FMF.

其他以 Elcam Medical Acal 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：FMF）

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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