FDA 510(k)

LT-300 SD數字式阴道鏡

K 號：K170446 · 2017-05-21

決定日期2017-05-21

產品代碼HEX

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

LT-300 SD Digital Video Colposcope is the device name listed in this FDA 510(k) record. The listed applicant is Lutech Industries, Inc.. It received FDA 510(k) clearance on 2017-05-21 under 510(k) number K170446. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LT-300 SD Digital Video Colposcope?

LT-300 SD Digital Video Colposcope is a medical device that received FDA 510(k) clearance on 2017-05-21. The listed applicant is Lutech Industries, Inc.. The 510(k) number is K170446.

When did LT-300 SD Digital Video Colposcope receive FDA 510(k) clearance?

LT-300 SD Digital Video Colposcope received FDA 510(k) clearance on 2017-05-21, under 510(k) number K170446.

Who is the listed applicant for LT-300 SD Digital Video Colposcope?

The FDA 510(k) record lists Lutech Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LT-300 SD Digital Video Colposcope?

The FDA product code for LT-300 SD Digital Video Colposcope is HEX.

其他以 Lutech Industries, Inc. 為申請人之記錄

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K160380LT-300 HD

相關器械（代碼：HEX）

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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