NeedleSmart Professional (NS Pro)
K号: K202073 · 2021-03-25
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决定日期2021-03-25
产品代码MTV
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
NeedleSmart Professional (NS Pro) is the device name listed in this FDA 510(k) record. The listed applicant is Needlesmart Limited. It received FDA 510(k) clearance on 2021-03-25 under 510(k) number K202073. The device is classified under product code MTV. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NeedleSmart Professional (NS Pro)?
NeedleSmart Professional (NS Pro) is a medical device that received FDA 510(k) clearance on 2021-03-25. The listed applicant is Needlesmart Limited. The 510(k) number is K202073.
When did NeedleSmart Professional (NS Pro) receive FDA 510(k) clearance?
NeedleSmart Professional (NS Pro) received FDA 510(k) clearance on 2021-03-25, under 510(k) number K202073.
Who is the listed applicant for NeedleSmart Professional (NS Pro)?
The FDA 510(k) record lists Needlesmart Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NeedleSmart Professional (NS Pro)?
The FDA product code for NeedleSmart Professional (NS Pro) is MTV.
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官方来源
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