MIO 血糖監測系統
K 號：K223722 · 2023-06-28
廣告
器材摘要
MIO Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Mio Labs, Inc.. It received FDA 510(k) clearance on 2023-06-28 under 510(k) number K223722. 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 MIO Blood Glucose Monitoring System?
MIO Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2023-06-28. The listed applicant is Mio Labs, Inc.. The 510(k) number is K223722.
When did MIO Blood Glucose Monitoring System receive FDA 510(k) clearance?
MIO Blood Glucose Monitoring System received FDA 510(k) clearance on 2023-06-28, under 510(k) number K223722.
Who is the listed applicant for MIO Blood Glucose Monitoring System?
The FDA 510(k) record lists Mio Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MIO Blood Glucose Monitoring System?
The FDA product code for MIO Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.
相關臨床試驗
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。
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 CareK262116TRUE 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 CorporationK240640Sejoy 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。
廣告