貝斯美 PEEP 過換氣閥
K 號：K160112 · 2016-04-29
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器材摘要
Besmed PEEP Valve is the device name listed in this FDA 510(k) record. The listed applicant is Besmed Health Business Corp. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K160112. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Besmed PEEP Valve?
Besmed PEEP Valve is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Besmed Health Business Corp. The 510(k) number is K160112.
When did Besmed PEEP Valve receive FDA 510(k) clearance?
Besmed PEEP Valve received FDA 510(k) clearance on 2016-04-29, under 510(k) number K160112.
Who is the listed applicant for Besmed PEEP Valve?
The FDA 510(k) record lists Besmed Health Business Corp as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Besmed PEEP Valve?
The FDA product code for Besmed PEEP Valve is BYE.
相關臨床試驗
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其他以 Besmed Health Business Corp 為申請人之記錄
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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