FDA 510(k)

Paxman 頭部冷卻器

K 號：K163484 · 2017-04-17

決定日期2017-04-17

產品代碼PMC

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Paxman Coolers Limited 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K173032Paxman 頭部冷卻器

相關器械（代碼：PMC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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