FDA 510(k)

Spectra S1Plus 及 Spectra S2 Plus

K 號：K150476 · 2016-04-15

決定日期2016-04-15

產品代碼HGX

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

Spectra S1Plus and Spectra S2 Plus is the device name listed in this FDA 510(k) record. The listed applicant is Uzinmedicare Co.. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K150476. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Spectra S1Plus and Spectra S2 Plus?

Spectra S1Plus and Spectra S2 Plus is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Uzinmedicare Co.. The 510(k) number is K150476.

When did Spectra S1Plus and Spectra S2 Plus receive FDA 510(k) clearance?

Spectra S1Plus and Spectra S2 Plus received FDA 510(k) clearance on 2016-04-15, under 510(k) number K150476.

Who is the listed applicant for Spectra S1Plus and Spectra S2 Plus?

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

What is the FDA product code for Spectra S1Plus and Spectra S2 Plus?

The FDA product code for Spectra S1Plus and Spectra S2 Plus is HGX.

其他以 Uzinmedicare Co. 為申請人之記錄

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相關器械（代碼：HGX）

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