FLOWpresso
K 號：K223729 · 2023-12-21
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器材摘要
FLOWpresso is the device name listed in this FDA 510(k) record. The listed applicant is Medella Health Limited. It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K223729. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the FLOWpresso?
FLOWpresso is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Medella Health Limited. The 510(k) number is K223729.
When did FLOWpresso receive FDA 510(k) clearance?
FLOWpresso received FDA 510(k) clearance on 2023-12-21, under 510(k) number K223729.
Who is the listed applicant for FLOWpresso?
The FDA 510(k) record lists Medella Health Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FLOWpresso?
The FDA product code for FLOWpresso is IRP.
相關臨床試驗
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相關器械（代碼：IRP）
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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