FDA 510(k)

Z-DOSE29

K 號：K170273 · 2017-04-28

決定日期2017-04-28

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

Z-DOSE29 is the device name listed in this FDA 510(k) record. The listed applicant is Zetta Medical Technologies, LLC. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K170273. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Z-DOSE29?

Z-DOSE29 is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Zetta Medical Technologies, LLC. The 510(k) number is K170273.

When did Z-DOSE29 receive FDA 510(k) clearance?

Z-DOSE29 received FDA 510(k) clearance on 2017-04-28, under 510(k) number K170273.

Who is the listed applicant for Z-DOSE29?

The FDA 510(k) record lists Zetta Medical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Z-DOSE29?

The FDA product code for Z-DOSE29 is JAK.

其他以 Zetta Medical Technologies, LLC 為申請人之記錄

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K172768ZOOM K160852Zia 醫療設備規範文本翻譯如下： Zia醫療設備規範說明：本產品已通過FDA（美國食品藥品管理局）認證，並獲得510(k)許可證。該產品已向FDA提交PMA（上市前批准）申請，並在NCT（臨床試驗登錄）登錄編號為[編號]的臨床試驗中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址以獲取更多資訊：識別碼：[識別碼] 網址：[網址] 注意：以上翻譯遵循「medical-regulatory-v1」政策，公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別碼和網址均未進行翻譯。

相關器械（代碼：JAK）

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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