FDA 510(k)

K-SHIELD Zen

K号: K220799 · 2022-08-29

决定日期2022-08-29

产品代码JKA

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

K-SHIELD Zen is the device name listed in this FDA 510(k) record. The listed applicant is Sb-Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2022-08-29 under 510(k) number K220799. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the K-SHIELD Zen?

K-SHIELD Zen is a medical device that received FDA 510(k) clearance on 2022-08-29. The listed applicant is Sb-Kawasumi Laboratories, Inc.. The 510(k) number is K220799.

When did K-SHIELD Zen receive FDA 510(k) clearance?

K-SHIELD Zen received FDA 510(k) clearance on 2022-08-29, under 510(k) number K220799.

Who is the listed applicant for K-SHIELD Zen?

The FDA 510(k) record lists Sb-Kawasumi Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-SHIELD Zen?

The FDA product code for K-SHIELD Zen is JKA.

列明Sb-Kawasumi Laboratories, 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。

K252355K-SHIELD Advantage PORT ACCESS INFUSION SET 带高压软管 K241855SB 刀 Jr2 (MD-47702 和 MD-47702L)K230408K-SHIELD Zen (型号：PBMH/ PBMA/ PBM)K223810Kawasumi多样本适配器带预装夹具（MBCH）

相关器械（代码：JKA）

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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