FDA 510(k)

安全型刀片（XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV）

K号: K240806 · 2024-05-21

决定日期2024-05-21

产品代码FMK

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

Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) 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 2024-05-21 under 510(k) number K240806. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)?

Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) is a medical device that received FDA 510(k) clearance on 2024-05-21. The listed applicant is Tianjin Huahong Technology Co., Ltd.. The 510(k) number is K240806.

When did Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) receive FDA 510(k) clearance?

Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) received FDA 510(k) clearance on 2024-05-21, under 510(k) number K240806.

Who is the listed applicant for Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)?

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 Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)?

The FDA product code for Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) is FMK.

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。

K262526安全采血针（XL）K262135刺针 K260845华宏锐器容器（HHR-I，HHR-II）K262211lancet K260191安全型刀片（XXXVII）K252490足跟棒安全刀片（HHZ-II，HHZ-III，HHZ-IV）

查看所有 16 个设备 →

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。