Pylant 監控器
K 號：K191858 · 2020-02-24
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器材摘要
Pylant Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Kal-Med, LLC. It received FDA 510(k) clearance on 2020-02-24 under 510(k) number K191858. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Pylant Monitor?
Pylant Monitor is a medical device that received FDA 510(k) clearance on 2020-02-24. The listed applicant is Kal-Med, LLC. The 510(k) number is K191858.
When did Pylant Monitor receive FDA 510(k) clearance?
Pylant Monitor received FDA 510(k) clearance on 2020-02-24, under 510(k) number K191858.
Who is the listed applicant for Pylant Monitor?
The FDA 510(k) record lists Kal-Med, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pylant Monitor?
The FDA product code for Pylant Monitor is BSK.
相關臨床試驗
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相關器械（代碼：BSK）
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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