灭菌Eol自动刀片；灭菌Eol刀片加长
K号: K243533 · 2025-01-13
广告
决定日期2025-01-13
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
Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus is the device name listed in this FDA 510(k) record. The listed applicant is Hlb Co., Ltd. Healthcare. It received FDA 510(k) clearance on 2025-01-13 under 510(k) number K243533. 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 Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus?
Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Hlb Co., Ltd. Healthcare. The 510(k) number is K243533.
When did Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus receive FDA 510(k) clearance?
Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus received FDA 510(k) clearance on 2025-01-13, under 510(k) number K243533.
Who is the listed applicant for Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus?
The FDA 510(k) record lists Hlb Co., Ltd. Healthcare as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus?
The FDA product code for Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus is FMK.
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。
相关器械（代码：FMK）
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）Tianjin Huahong Technology Co., Ltd.K261045Verifine 安全采血针Promisemed Hangzhou Meditech Co., Ltd.K260191安全型刀片（XXXVII）Tianjin Huahong Technology Co., Ltd.K253605安全足跟注射针Ningbo Medsun Medical Co., Ltd.K252490足跟棒安全刀片（HHZ-II，HHZ-III，HHZ-IV）Tianjin Huahong Technology Co., Ltd.K251694安全注射针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。
广告