FDA 510(k)血漿飛行
K 號:K200351 · 2020-08-05
決定日期2020-08-05
產品代碼IRP
諮詢委員會PM
決定相當於
器材摘要
PlasmaFlight is the device name listed in this FDA 510(k) record. The listed applicant is Manamed, Inc.. It received FDA 510(k) clearance on 2020-08-05 under 510(k) number K200351. 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 PlasmaFlight?
PlasmaFlight is a medical device that received FDA 510(k) clearance on 2020-08-05. The listed applicant is Manamed, Inc.. The 510(k) number is K200351.
When did PlasmaFlight receive FDA 510(k) clearance?
PlasmaFlight received FDA 510(k) clearance on 2020-08-05, under 510(k) number K200351.
Who is the listed applicant for PlasmaFlight?
The FDA 510(k) record lists Manamed, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PlasmaFlight?
The FDA product code for PlasmaFlight is IRP.
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其他以 Manamed, Inc. 為申請人之記錄
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相關器械(代碼:IRP)
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