FDA 510(k)

NeatNick Heel Safety Lancet

K号: K223370 · 2023-02-13

决定日期2023-02-13

产品代码FMK

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决定实质等同

器械摘要

NeatNick Heel Safety Lancet is the device name listed in this FDA 510(k) record. The listed applicant is Facet Technologies, LLC. It received FDA 510(k) clearance on 2023-02-13 under 510(k) number K223370. 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 NeatNick Heel Safety Lancet?

NeatNick Heel Safety Lancet is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is Facet Technologies, LLC. The 510(k) number is K223370.

When did NeatNick Heel Safety Lancet receive FDA 510(k) clearance?

NeatNick Heel Safety Lancet received FDA 510(k) clearance on 2023-02-13, under 510(k) number K223370.

Who is the listed applicant for NeatNick Heel Safety Lancet?

The FDA 510(k) record lists Facet Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeatNick Heel Safety Lancet?

The FDA product code for NeatNick Heel Safety Lancet is FMK.

列明Facet Technologies, LLC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。

K232912Facet Aurora 可重复使用注射针座 K223099Facet 海牛可重复使用注射针座 K222539Facet 血液注射针 K221433Facet 28G 通用注射针

官方来源

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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。