Nurture Rest
K号: K172962 · 2018-01-18
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决定日期2018-01-18
产品代码OUW
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
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.
常见问题
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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官方来源
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