FDA 510(k)刺针 (HH-XV-T)
K号: K253706 · 2025-12-09
决定日期2025-12-09
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
Lancing device (HH-XV-T) is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Huahong Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-09 under 510(k) number K253706. 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 Lancing device (HH-XV-T)?
Lancing device (HH-XV-T) is a medical device that received FDA 510(k) clearance on 2025-12-09. The listed applicant is Tianjin Huahong Technology Co., Ltd.. The 510(k) number is K253706.
When did Lancing device (HH-XV-T) receive FDA 510(k) clearance?
Lancing device (HH-XV-T) received FDA 510(k) clearance on 2025-12-09, under 510(k) number K253706.
Who is the listed applicant for Lancing device (HH-XV-T)?
FDA 510(k)记录将天津华宏科技有限公司列为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for Lancing device (HH-XV-T)?
The FDA product code for Lancing device (HH-XV-T) 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。
列明Tianjin Huahong Technology Co., Ltd.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。
查看所有 16 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.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.K232912Facet Aurora 可重复使用注射针座Facet Technologies, LLC