FDA 510(k)

Polysafety BC，Polysafety BC Adva，Polywin Safety，Polywin Safety Adva

K号: K231401 · 2023-09-21

决定日期2023-09-21

产品代码FOZ

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva is the device name listed in this FDA 510(k) record. The listed applicant is Poly Medicure Limited. It received FDA 510(k) clearance on 2023-09-21 under 510(k) number K231401. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva?

Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva is a medical device that received FDA 510(k) clearance on 2023-09-21. The listed applicant is Poly Medicure Limited. The 510(k) number is K231401.

When did Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva receive FDA 510(k) clearance?

Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva received FDA 510(k) clearance on 2023-09-21, under 510(k) number K231401.

Who is the listed applicant for Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva?

The FDA 510(k) record lists Poly Medicure Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva?

The FDA product code for Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva is FOZ.

列明Poly Medicure Limited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。

K252513Polywin Safety（14G x 51mm；16G x 51mm；18G x 64mm；20G x 64mm；20G x 45mm；22G x 64mm；22G x 45mm；24G x 32mm；24G x 14mm，26G x 14mm）；Polywin Safety Adva（20G x 45mm；22G x 64mm；22G x 45mm；24G x 32mm；24G x 14mm；14G x 51mm；16G x 51mm；18G x 64mm；20G x 64mm，26G x 14mm）K252677Polyshield 安全静脉留置针 K232234Nouvo安全套件 K230616Polyguard 和 Polyshield 安全 IV 导管 K220312Polyfusion IV 输液器套装

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。