FDA 510(k)

安全足跟注射针

K号: K253605 · 2026-02-20

决定日期2026-02-20

产品代码FMK

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决定实质等同

器械摘要

Safety Heel Lancet is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Medsun Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-02-20 under 510(k) number K253605. 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 Heel Lancet?

Safety Heel Lancet is a medical device that received FDA 510(k) clearance on 2026-02-20. The listed applicant is Ningbo Medsun Medical Co., Ltd.. The 510(k) number is K253605.

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

Safety Heel Lancet received FDA 510(k) clearance on 2026-02-20, under 510(k) number K253605.

Who is the listed applicant for Safety Heel Lancet?

The FDA 510(k) record lists Ningbo Medsun Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safety Heel Lancet?

The FDA product code for Safety Heel Lancet is FMK.

列明Ningbo Medsun Medical 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。

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