針智專業版（NS Pro）
K 號：K202073 · 2021-03-25
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決定日期2021-03-25
產品代碼MTV
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
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.
常見問題
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.
相關臨床試驗
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官方來源
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