FDA 510(k)

Paxman头皮冷却器

K号: K163484 · 2017-04-17

决定日期2017-04-17

产品代码PMC

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决定实质等同

器械摘要

Paxman Scalp Cooler is the device name listed in this FDA 510(k) record. The listed applicant is Paxman Coolers Limited. It received FDA 510(k) clearance on 2017-04-17 under 510(k) number K163484. The device is classified under product code PMC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Paxman Scalp Cooler?

Paxman Scalp Cooler is a medical device that received FDA 510(k) clearance on 2017-04-17. The listed applicant is Paxman Coolers Limited. The 510(k) number is K163484.

When did Paxman Scalp Cooler receive FDA 510(k) clearance?

Paxman Scalp Cooler received FDA 510(k) clearance on 2017-04-17, under 510(k) number K163484.

Who is the listed applicant for Paxman Scalp Cooler?

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

What is the FDA product code for Paxman Scalp Cooler?

The FDA product code for Paxman Scalp Cooler is PMC.

列明Paxman Coolers 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。

K173032Paxman头皮冷却器

官方来源

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