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FDA 510(k)

RIGHTEST 刺针器 GD500，GE 刺针器，iGlucose 刺针器

K号: K221062 · 2022-09-26

申请人Bionime Corporation
决定日期2022-09-26
产品代码QRL
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决定实质等同

器械摘要

RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device is the device name listed in this FDA 510(k) record. The listed applicant is Bionime Corporation. It received FDA 510(k) clearance on 2022-09-26 under 510(k) number K221062. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device?

RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device is a medical device that received FDA 510(k) clearance on 2022-09-26. The listed applicant is Bionime Corporation. The 510(k) number is K221062.

When did RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device receive FDA 510(k) clearance?

RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device received FDA 510(k) clearance on 2022-09-26, under 510(k) number K221062.

Who is the listed applicant for RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device?

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 RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device?

The FDA product code for RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device is QRL.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Bionime Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K240637RIGHTEST 血糖监测系统 Max TelK231192RIGHTEST 血糖监测系统 Max TelK190564Rightest 血糖监测系统 GM700S，Rightest 血糖监测系统 GM700SBK173638Rightest 血糖监测系统 Max，Rightest 血糖监测系统 Max Plus，GE 血糖监测系统 Max，GE 血糖监测系统 Max PlusK173139Rightest 血糖监测系统 Wiz，Rightest 血糖监测系统 Wiz PlusK170143GE血糖监测系统180，GE血糖监测系统182，Rightest血糖监测系统GM280，Rightest血糖监测系统GM280B

查看所有 8 个设备 →

相关器械（代码：QRL）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262135刺针Tianjin Huahong Technology Co., Ltd.K262211lancetTianjin Huahong Technology Co., Ltd.K260122穿刺器（PressGo, LDE3, LDE3AST, LDE5, EasyStep）SteriLance Medical (Suzhou), Inc.K253706刺针 (HH-XV-T)Tianjin Huahong Technology Co., Ltd.K250813MICROLET®NEXT 2 刺针装置Ascensia Diabetes Care U.S., Inc.K243306lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); 刺针 (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)Tianjin Huahong Technology Co., Ltd.

官方来源

在 FDA 数据库中查看 →

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