Neo Sculptor (OF-NEO001)
K 號：K242186 · 2024-09-17
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器材摘要
Neo Sculptor (OF-NEO001) is the device name listed in this FDA 510(k) record. The listed applicant is Ofan Intelligent Technology (Guangzhou) Co. , Ltd.. It received FDA 510(k) clearance on 2024-09-17 under 510(k) number K242186. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Neo Sculptor (OF-NEO001)?
Neo Sculptor (OF-NEO001) is a medical device that received FDA 510(k) clearance on 2024-09-17. The listed applicant is Ofan Intelligent Technology (Guangzhou) Co. , Ltd.. The 510(k) number is K242186.
When did Neo Sculptor (OF-NEO001) receive FDA 510(k) clearance?
Neo Sculptor (OF-NEO001) received FDA 510(k) clearance on 2024-09-17, under 510(k) number K242186.
Who is the listed applicant for Neo Sculptor (OF-NEO001)?
The FDA 510(k) record lists Ofan Intelligent Technology (Guangzhou) Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Neo Sculptor (OF-NEO001)?
The FDA product code for Neo Sculptor (OF-NEO001) is NGX.
相關臨床試驗
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相關器械（代碼：NGX）
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。
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官方來源
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