FDA 510(k)

一次性安全注射针

K号: K221521 · 2022-10-28

决定日期2022-10-28

产品代码FMK

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决定实质等同

器械摘要

Disposable Safety Lancet is the device name listed in this FDA 510(k) record. The listed applicant is SteriLance Medical (Suzhou), Inc.. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K221521. 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 Disposable Safety Lancet?

Disposable Safety Lancet is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is SteriLance Medical (Suzhou), Inc.. The 510(k) number is K221521.

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

Disposable Safety Lancet received FDA 510(k) clearance on 2022-10-28, under 510(k) number K221521.

Who is the listed applicant for Disposable Safety Lancet?

FDA 510(k)记录将SteriLance Medical (Suzhou), Inc.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Disposable Safety Lancet?

The FDA product code for Disposable Safety Lancet is FMK.

列明SteriLance Medical (Suzhou), Inc.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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官方来源

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