FDA 510(k)

OptiScanner 5000 葡萄糖監測系統

K 號：K162042 · 2017-10-16

決定日期2017-10-16

產品代碼LZF

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

OptiScanner 5000 Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Optiscan Biomedical Corp.. It received FDA 510(k) clearance on 2017-10-16 under 510(k) number K162042. The device is classified under product code LZF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OptiScanner 5000 Glucose Monitoring System?

OptiScanner 5000 Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2017-10-16. The listed applicant is Optiscan Biomedical Corp.. The 510(k) number is K162042.

When did OptiScanner 5000 Glucose Monitoring System receive FDA 510(k) clearance?

OptiScanner 5000 Glucose Monitoring System received FDA 510(k) clearance on 2017-10-16, under 510(k) number K162042.

Who is the listed applicant for OptiScanner 5000 Glucose Monitoring System?

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

What is the FDA product code for OptiScanner 5000 Glucose Monitoring System?

The FDA product code for OptiScanner 5000 Glucose Monitoring System is LZF.

相關器械（代碼：LZF）

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K192785OptiScanner® 5000 葡萄糖監測系統Optiscan Biomedical Corporation

官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：LZF）

官方來源