Alpha Control Liner System (ACLS)
K 號：K223738 · 2023-01-11
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器材摘要
Alpha Control Liner System (ACLS) is the device name listed in this FDA 510(k) record. The listed applicant is Coapt. It received FDA 510(k) clearance on 2023-01-11 under 510(k) number K223738. 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 Alpha Control Liner System (ACLS)?
Alpha Control Liner System (ACLS) is a medical device that received FDA 510(k) clearance on 2023-01-11. The listed applicant is Coapt. The 510(k) number is K223738.
When did Alpha Control Liner System (ACLS) receive FDA 510(k) clearance?
Alpha Control Liner System (ACLS) received FDA 510(k) clearance on 2023-01-11, under 510(k) number K223738.
Who is the listed applicant for Alpha Control Liner System (ACLS)?
The FDA 510(k) record lists Coapt as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Alpha Control Liner System (ACLS)?
The FDA product code for Alpha Control Liner System (ACLS) is GXY.
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其他以 Coapt 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：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
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