Medifun 刺激器，型号 LD-E1
K号: K231797 · 2023-11-22
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决定日期2023-11-22
产品代码QRL
咨询委员会SU
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决定实质等同
器械摘要
Medifun Lancing Device, Model No. LD-E1 is the device name listed in this FDA 510(k) record. The listed applicant is Medifun Corporation. It received FDA 510(k) clearance on 2023-11-22 under 510(k) number K231797. 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 Medifun Lancing Device, Model No. LD-E1?
Medifun Lancing Device, Model No. LD-E1 is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Medifun Corporation. The 510(k) number is K231797.
When did Medifun Lancing Device, Model No. LD-E1 receive FDA 510(k) clearance?
Medifun Lancing Device, Model No. LD-E1 received FDA 510(k) clearance on 2023-11-22, under 510(k) number K231797.
Who is the listed applicant for Medifun Lancing Device, Model No. LD-E1?
The FDA 510(k) record lists Medifun Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Medifun Lancing Device, Model No. LD-E1?
The FDA product code for Medifun Lancing Device, Model No. LD-E1 is QRL.
相关临床试验
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列明Medifun 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。
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 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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