Genteel 刺激器
K号: K153670 · 2016-05-12
广告
器械摘要
Genteel Lancing Device is the device name listed in this FDA 510(k) record. The listed applicant is Genteel, LLC. It received FDA 510(k) clearance on 2016-05-12 under 510(k) number K153670. 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 Genteel Lancing Device?
Genteel Lancing Device is a medical device that received FDA 510(k) clearance on 2016-05-12. The listed applicant is Genteel, LLC. The 510(k) number is K153670.
When did Genteel Lancing Device receive FDA 510(k) clearance?
Genteel Lancing Device received FDA 510(k) clearance on 2016-05-12, under 510(k) number K153670.
Who is the listed applicant for Genteel Lancing Device?
The FDA 510(k) record lists Genteel, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Genteel Lancing Device?
The FDA product code for Genteel Lancing Device 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