FDA 510(k)

MDT2 BLE 自我監測血糖系統

K 號：K190189 · 2019-11-01

決定日期2019-11-01

產品代碼NBW

諮詢委員會CH

決定相當於

器材摘要

MDT2 BLE Self-Monitoring Blood Glucose System is the device name listed in this FDA 510(k) record. The listed applicant is Eps Bio Technology Corp.. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K190189. 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 MDT2 BLE Self-Monitoring Blood Glucose System?

MDT2 BLE Self-Monitoring Blood Glucose System is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Eps Bio Technology Corp.. The 510(k) number is K190189.

When did MDT2 BLE Self-Monitoring Blood Glucose System receive FDA 510(k) clearance?

MDT2 BLE Self-Monitoring Blood Glucose System received FDA 510(k) clearance on 2019-11-01, under 510(k) number K190189.

Who is the listed applicant for MDT2 BLE Self-Monitoring Blood Glucose System?

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

What is the FDA product code for MDT2 BLE Self-Monitoring Blood Glucose System?

The FDA product code for MDT2 BLE Self-Monitoring Blood Glucose System is NBW. This falls under the OB/GYN category.

其他以 Eps Bio Technology 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。

K201258EASYMAX Tag 自監測血糖系統 K182057EasyMax BT 自動監測血糖系統

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。