單頻脈搏
K 號：K182905 · 2018-12-14
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器材摘要
UniPulse is the device name listed in this FDA 510(k) record. The listed applicant is Seaward Group. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K182905. The device is classified under product code DRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the UniPulse?
UniPulse is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Seaward Group. The 510(k) number is K182905.
When did UniPulse receive FDA 510(k) clearance?
UniPulse received FDA 510(k) clearance on 2018-12-14, under 510(k) number K182905.
Who is the listed applicant for UniPulse?
The FDA 510(k) record lists Seaward Group as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UniPulse?
The FDA product code for UniPulse is DRL.
相關臨床試驗
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相關器械（代碼：DRL）
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。
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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