培養休息
K 號：K172962 · 2018-01-18
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決定日期2018-01-18
產品代碼OUW
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
Nurture Rest is the device name listed in this FDA 510(k) record. The listed applicant is Neonatal Loving Kare, Inc.. It received FDA 510(k) clearance on 2018-01-18 under 510(k) number K172962. The device is classified under product code OUW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Nurture Rest?
Nurture Rest is a medical device that received FDA 510(k) clearance on 2018-01-18. The listed applicant is Neonatal Loving Kare, Inc.. The 510(k) number is K172962.
When did Nurture Rest receive FDA 510(k) clearance?
Nurture Rest received FDA 510(k) clearance on 2018-01-18, under 510(k) number K172962.
Who is the listed applicant for Nurture Rest?
The FDA 510(k) record lists Neonatal Loving Kare, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Nurture Rest?
The FDA product code for Nurture Rest is OUW.
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官方來源
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