PeriFlux6000
K 號:K152930 · 2016-05-05
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器材摘要
PeriFlux6000 is the device name listed in this FDA 510(k) record. The listed applicant is Perimed AB. It received FDA 510(k) clearance on 2016-05-05 under 510(k) number K152930. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the PeriFlux6000?
PeriFlux6000 is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is Perimed AB. The 510(k) number is K152930.
When did PeriFlux6000 receive FDA 510(k) clearance?
PeriFlux6000 received FDA 510(k) clearance on 2016-05-05, under 510(k) number K152930.
Who is the listed applicant for PeriFlux6000?
The FDA 510(k) record lists Perimed AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PeriFlux6000?
The FDA product code for PeriFlux6000 is DPW.
相關臨床試驗
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相關器械(代碼:DPW)
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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