FDA 510(k)

K-SHIELD Zen (型号：PBMH/ PBMA/ PBM)

K号: K230408 · 2023-06-01

决定日期2023-06-01

产品代码JKA

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决定实质等同

器械摘要

K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) 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 2023-06-01 under 510(k) number K230408. 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 (Model Numbers: PBMH/ PBMA/ PBM)?

K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Sb-Kawasumi Laboratories, Inc.. The 510(k) number is K230408.

When did K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) receive FDA 510(k) clearance?

K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) received FDA 510(k) clearance on 2023-06-01, under 510(k) number K230408.

Who is the listed applicant for K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)?

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 (Model Numbers: PBMH/ PBMA/ PBM)?

The FDA product code for K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) 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)K223810Kawasumi多样本适配器带预装夹具（MBCH）K220799K-SHIELD Zen

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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