FDA 510(k)

多確GK連結血糖及酮體監測系統

K 號：K201880 · 2021-10-15

決定日期2021-10-15

產品代碼NBW

諮詢委員會CH

決定相當於

器材摘要

MultiSure GK Link Blood Glucose and Ketone Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2021-10-15 under 510(k) number K201880. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the MultiSure GK Link Blood Glucose and Ketone Monitoring System?

MultiSure GK Link Blood Glucose and Ketone Monitoring System is a medical device that received FDA 510(k) clearance on 2021-10-15. The listed applicant is Apex BioTechnology Corp.. The 510(k) number is K201880.

When did MultiSure GK Link Blood Glucose and Ketone Monitoring System receive FDA 510(k) clearance?

MultiSure GK Link Blood Glucose and Ketone Monitoring System received FDA 510(k) clearance on 2021-10-15, under 510(k) number K201880.

Who is the listed applicant for MultiSure GK Link Blood Glucose and Ketone Monitoring System?

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

What is the FDA product code for MultiSure GK Link Blood Glucose and Ketone Monitoring System?

The FDA product code for MultiSure GK Link Blood Glucose and Ketone Monitoring System is NBW. This falls under the OB/GYN category.

其他以 Apex BioTechnology Corp. 為申請人之記錄

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。

K242209UASure II 血鹼酸監測系統 K222234GlucoSure ADVANCE 鏈接血糖監測系統 K220421BGM039 血糖監測系統，BGM039 鏈接血糖監測系統 K212140GlucoSure Link 血糖監測系統 K202534MTM301 血糖及酮體監測系統 K213887GAL-1A Plus 適用醫療設備監管系統

查看所有 12 項裝置 →

相關器械（代碼：NBW）

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。

K260545CONTOUR® PLUS BLUE 血糖監測系統；CONTOUR® NEXT GEN 血糖監測系統；CONTOUR® NEXT ONE 血糖監測系統Ascensia Diabetes Care K262116TRUE METRIX 自我監測血糖系統Trividia Health, Inc.K250085On Call® 確保 GK 血糖與酮體監測系統；On Call® 確保同步 GK 血糖與酮體監測系統ACON Laboratories, Inc.K243060TeleRPM Gen2 血糖監測系統Guangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST 血糖監測系統 Max TelBionime Corporation K240640Sejoy 血糖監測系統；Sejoy 先進連接血糖監測系統Sejoy Biomedical Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。