FDA 510(k)

嬰兒足跟加熱器（型號24401）及WarmGel嬰兒足跟加熱器（型號20418）

K 號：K151845 · 2016-03-18

決定日期2016-03-18

產品代碼MPO

諮詢委員會PM

決定相當於

器材摘要

Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 2016-03-18 under 510(k) number K151845. The device is classified under product code MPO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)?

Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K151845.

When did Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) receive FDA 510(k) clearance?

Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) received FDA 510(k) clearance on 2016-03-18, under 510(k) number K151845.

Who is the listed applicant for Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)?

FDA 510(k) 記錄將 CooperSurgical, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)?

The FDA product code for Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) is MPO.

其他以 CooperSurgical, Inc. 為申請人之記錄

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相關器械（代碼：MPO）

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。

K221154嬰兒足跟加熱器™；足跟親密者®International Biomedical

官方來源

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