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FDA 510(k)

GE 血糖監測系統 180，GE 血糖監測系統 182，Rightest 血糖監測系統 GM280，Rightest 血糖監測系統 GM280B，

K 號：K170143 · 2017-07-06

申請人Bionime Corporation
決定日期2017-07-06
產品代碼NBW
諮詢委員會CH
決定相當於

器材摘要

GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, is the device name listed in this FDA 510(k) record. The listed applicant is Bionime Corporation. It received FDA 510(k) clearance on 2017-07-06 under 510(k) number K170143. 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 GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,?

GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, is a medical device that received FDA 510(k) clearance on 2017-07-06. The listed applicant is Bionime Corporation. The 510(k) number is K170143.

When did GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, receive FDA 510(k) clearance?

GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, received FDA 510(k) clearance on 2017-07-06, under 510(k) number K170143.

Who is the listed applicant for GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,?

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

What is the FDA product code for GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,?

The FDA product code for GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, is NBW. This falls under the OB/GYN category.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Bionime Corporation 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。

K240637RIGHTEST 血糖監測系統 Max TelK231192RIGHTEST 血糖監測系統 Max TelK221062RIGHTEST 穿刺器 GD500，GE 穿刺器，iGlucose 穿刺器K190564Rightest 血糖監測系統 GM700S，Rightest 血糖監測系統 GM700SBK173638Rightest 血糖監測系統 Max，Rightest 血糖監測系統 Max Plus，GE 血糖監測系統 Max，GE 血糖監測系統 Max PlusK173139Rightest 血糖監測系統 Wiz，Rightest 血糖監測系統 Wiz Plus

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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 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

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