FDA 510(k)

Zia 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。

K 號：K160852 · 2016-12-15

決定日期2016-12-15

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Zia 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 2016-12-15 under 510(k) number K160852. 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 Zia?

Zia is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Zetta Medical Technologies, LLC. The 510(k) number is K160852.

When did Zia receive FDA 510(k) clearance?

Zia received FDA 510(k) clearance on 2016-12-15, under 510(k) number K160852.

Who is the listed applicant for Zia?

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 Zia?

The FDA product code for Zia is LLZ.