FDA 510(k)

ZOOM

K 號：K172768 · 2018-04-24

決定日期2018-04-24

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

ZOOM 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 2018-04-24 under 510(k) number K172768. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ZOOM?

ZOOM is a medical device that received FDA 510(k) clearance on 2018-04-24. The listed applicant is Zetta Medical Technologies, LLC. The 510(k) number is K172768.

When did ZOOM receive FDA 510(k) clearance?

ZOOM received FDA 510(k) clearance on 2018-04-24, under 510(k) number K172768.

Who is the listed applicant for ZOOM?

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 ZOOM?

The FDA product code for ZOOM is LLZ.

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

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K170273Z-DOSE29 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：LLZ）

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。

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio分析Replasia BV K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

官方來源

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