LDE4 刺针装置
K号: K222656 · 2022-11-23
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器械摘要
LDE4 Lancing Device is the device name listed in this FDA 510(k) record. The listed applicant is I-Sens, Inc.. It received FDA 510(k) clearance on 2022-11-23 under 510(k) number K222656. 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 LDE4 Lancing Device?
LDE4 Lancing Device is a medical device that received FDA 510(k) clearance on 2022-11-23. The listed applicant is I-Sens, Inc.. The 510(k) number is K222656.
When did LDE4 Lancing Device receive FDA 510(k) clearance?
LDE4 Lancing Device received FDA 510(k) clearance on 2022-11-23, under 510(k) number K222656.
Who is the listed applicant for LDE4 Lancing Device?
The FDA 510(k) record lists I-Sens, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LDE4 Lancing Device?
The FDA product code for LDE4 Lancing Device is QRL.
相关临床试验
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列明I-Sens, Inc.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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