CryoGlow (FW3XXXX)
K 號：K242796 · 2024-11-27
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器材摘要
CryoGlow (FW3XXXX) is the device name listed in this FDA 510(k) record. The listed applicant is Sharkninja Operating, LLC. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K242796. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CryoGlow (FW3XXXX)?
CryoGlow (FW3XXXX) is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Sharkninja Operating, LLC. The 510(k) number is K242796.
When did CryoGlow (FW3XXXX) receive FDA 510(k) clearance?
CryoGlow (FW3XXXX) received FDA 510(k) clearance on 2024-11-27, under 510(k) number K242796.
Who is the listed applicant for CryoGlow (FW3XXXX)?
The FDA 510(k) record lists Sharkninja Operating, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CryoGlow (FW3XXXX)?
The FDA product code for CryoGlow (FW3XXXX) is OHS.
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相關器械（代碼：OHS）
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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