FDA 510(k)

水溫-溫度新生兒皮膚溫度探針蓋

K 號：K191425 · 2020-01-21

決定日期2020-01-21

產品代碼FMT

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Hydro-Temp Neonatal Skin Temperature Probe Cover is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2020-01-21 under 510(k) number K191425. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hydro-Temp Neonatal Skin Temperature Probe Cover?

Hydro-Temp Neonatal Skin Temperature Probe Cover is a medical device that received FDA 510(k) clearance on 2020-01-21. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K191425.

When did Hydro-Temp Neonatal Skin Temperature Probe Cover receive FDA 510(k) clearance?

Hydro-Temp Neonatal Skin Temperature Probe Cover received FDA 510(k) clearance on 2020-01-21, under 510(k) number K191425.

Who is the listed applicant for Hydro-Temp Neonatal Skin Temperature Probe Cover?

The FDA 510(k) record lists Deroyal Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hydro-Temp Neonatal Skin Temperature Probe Cover?

The FDA product code for Hydro-Temp Neonatal Skin Temperature Probe Cover is FMT.

其他以 Deroyal Industries, Inc. 為申請人之記錄

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相關器械（代碼：FMT）

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。

K243606Babyroo TN300Draeger Medical Systems, Inc.K230278Babyroo TN300Draeger Medical Systems, Inc.K213551長頸鹿全能床護理站 CS1Datex Ohmeda, Inc.K201628Panda iRes 加熱器，Giraffe 加熱器GE Healthcare K200319HYDRO-TEMP 新生兒皮膚表面溫度感測器，HYDRO-TEMP 新生兒皮膚表面溫度感測器配接線Deroyal Industries, Inc.K173516NuBorne嬰兒保溫器International Biomedical

官方來源

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