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FDA 510(k)

TRUEdraw Lancing Device, Mini Lancing Device

K号: K221072 · 2022-10-18

申请人Trividia Health
决定日期2022-10-18
产品代码QRL
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

TRUEdraw Lancing Device, Mini Lancing Device is the device name listed in this FDA 510(k) record. The listed applicant is Trividia Health. It received FDA 510(k) clearance on 2022-10-18 under 510(k) number K221072. 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 TRUEdraw Lancing Device, Mini Lancing Device?

TRUEdraw Lancing Device, Mini Lancing Device is a medical device that received FDA 510(k) clearance on 2022-10-18. The listed applicant is Trividia Health. The 510(k) number is K221072.

When did TRUEdraw Lancing Device, Mini Lancing Device receive FDA 510(k) clearance?

TRUEdraw Lancing Device, Mini Lancing Device received FDA 510(k) clearance on 2022-10-18, under 510(k) number K221072.

Who is the listed applicant for TRUEdraw Lancing Device, Mini Lancing Device?

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

What is the FDA product code for TRUEdraw Lancing Device, Mini Lancing Device?

The FDA product code for TRUEdraw Lancing Device, Mini 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

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.

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