FDA 510(k)

Cardinal HealthTM多涂层开放式防护服

K号: K182830 · 2019-04-26

决定日期2019-04-26

产品代码QPC

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决定实质等同

器械摘要

Cardinal HealthTM Poly-Coated Open-Back Protective Gown is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2019-04-26 under 510(k) number K182830. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cardinal HealthTM Poly-Coated Open-Back Protective Gown?

Cardinal HealthTM Poly-Coated Open-Back Protective Gown is a medical device that received FDA 510(k) clearance on 2019-04-26. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K182830.

When did Cardinal HealthTM Poly-Coated Open-Back Protective Gown receive FDA 510(k) clearance?

Cardinal HealthTM Poly-Coated Open-Back Protective Gown received FDA 510(k) clearance on 2019-04-26, under 510(k) number K182830.

Who is the listed applicant for Cardinal HealthTM Poly-Coated Open-Back Protective Gown?

The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardinal HealthTM Poly-Coated Open-Back Protective Gown?

The FDA product code for Cardinal HealthTM Poly-Coated Open-Back Protective Gown is QPC.

列明Cardinal Health200, 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。

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官方来源

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