FDA 510(k)

Prestige Ameritech 儿童口罩

K 號：K160100 · 2016-10-07

決定日期2016-10-07

產品代碼OXZ

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

Prestige Ameritech Pediatric/Child’s Face mask is the device name listed in this FDA 510(k) record. The listed applicant is Prestige Ameritech. It received FDA 510(k) clearance on 2016-10-07 under 510(k) number K160100. The device is classified under product code OXZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Prestige Ameritech Pediatric/Child’s Face mask?

Prestige Ameritech Pediatric/Child’s Face mask is a medical device that received FDA 510(k) clearance on 2016-10-07. The listed applicant is Prestige Ameritech. The 510(k) number is K160100.

When did Prestige Ameritech Pediatric/Child’s Face mask receive FDA 510(k) clearance?

Prestige Ameritech Pediatric/Child’s Face mask received FDA 510(k) clearance on 2016-10-07, under 510(k) number K160100.

Who is the listed applicant for Prestige Ameritech Pediatric/Child’s Face mask?

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

What is the FDA product code for Prestige Ameritech Pediatric/Child’s Face mask?

The FDA product code for Prestige Ameritech Pediatric/Child’s Face mask is OXZ.

其他以 Prestige Ameritech 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。

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相關器械（代碼：OXZ）

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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