心臟節拍器
K 號：K203378 · 2021-03-31
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器材摘要
Pulsehaler is the device name listed in this FDA 510(k) record. The listed applicant is Respinova, Ltd.. It received FDA 510(k) clearance on 2021-03-31 under 510(k) number K203378. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Pulsehaler?
Pulsehaler is a medical device that received FDA 510(k) clearance on 2021-03-31. The listed applicant is Respinova, Ltd.. The 510(k) number is K203378.
When did Pulsehaler receive FDA 510(k) clearance?
Pulsehaler received FDA 510(k) clearance on 2021-03-31, under 510(k) number K203378.
Who is the listed applicant for Pulsehaler?
The FDA 510(k) record lists Respinova, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pulsehaler?
The FDA product code for Pulsehaler is BWF.
相關臨床試驗
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相關器械（代碼：BWF）
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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