冰帽產品線
K 號：K243788 · 2025-03-13
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器材摘要
IceCap product line is the device name listed in this FDA 510(k) record. The listed applicant is Bioserenity Medical Devices Group. It received FDA 510(k) clearance on 2025-03-13 under 510(k) number K243788. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the IceCap product line?
IceCap product line is a medical device that received FDA 510(k) clearance on 2025-03-13. The listed applicant is Bioserenity Medical Devices Group. The 510(k) number is K243788.
When did IceCap product line receive FDA 510(k) clearance?
IceCap product line received FDA 510(k) clearance on 2025-03-13, under 510(k) number K243788.
Who is the listed applicant for IceCap product line?
The FDA 510(k) record lists Bioserenity Medical Devices Group as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IceCap product line?
The FDA product code for IceCap product line is GXY.
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相關器械（代碼：GXY）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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