FDA 510(k)

即時應用Express手機血糖監測系統

K 號：K180196 · 2018-03-07

決定日期2018-03-07

產品代碼NBW

諮詢委員會CH

決定相當於

器材摘要

On Call Express Mobile Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2018-03-07 under 510(k) number K180196. 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 On Call Express Mobile Blood Glucose Monitoring System?

On Call Express Mobile Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-03-07. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K180196.

When did On Call Express Mobile Blood Glucose Monitoring System receive FDA 510(k) clearance?

On Call Express Mobile Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-03-07, under 510(k) number K180196.

Who is the listed applicant for On Call Express Mobile Blood Glucose Monitoring System?

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

What is the FDA product code for On Call Express Mobile Blood Glucose Monitoring System?

The FDA product code for On Call Express Mobile Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

其他以 ACON Laboratories, Inc. 為申請人之記錄

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K261212Flowflex Plus RSV + 流行性感冒A/B + COVID 快速檢測 K251697Flowflex® Plus 醍醐A 快速測試條；Flowflex® Plus 醍醐A 快速測試卡 K251749Flowflex Plus RSV + 流行性感冒A/B + COVID家庭檢測 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 K250377Flowflex Plus COVID-19 + 流感A/B 家庭檢測 K232715Distinct®數位懷孕檢測器

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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

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