葉平滑
K 號：K212697 · 2021-11-19
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器材摘要
Leaf Smooth is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Leaflife Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-19 under 510(k) number K212697. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Leaf Smooth?
Leaf Smooth is a medical device that received FDA 510(k) clearance on 2021-11-19. The listed applicant is Shenzhen Leaflife Technology Co., Ltd.. The 510(k) number is K212697.
When did Leaf Smooth receive FDA 510(k) clearance?
Leaf Smooth received FDA 510(k) clearance on 2021-11-19, under 510(k) number K212697.
Who is the listed applicant for Leaf Smooth?
The FDA 510(k) record lists Shenzhen Leaflife Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Leaf Smooth?
The FDA product code for Leaf Smooth is OHT.
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其他以 Shenzhen Leaflife Technology Co., Ltd. 為申請人之記錄
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。
相關器械（代碼：OHT）
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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