MyoWorx™ TM20
K 號:K192746 · 2021-10-19
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器材摘要
MyoWorx TM20 is the device name listed in this FDA 510(k) record. The listed applicant is Myoworx, Inc.. It received FDA 510(k) clearance on 2021-10-19 under 510(k) number K192746. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MyoWorx TM20?
MyoWorx TM20 is a medical device that received FDA 510(k) clearance on 2021-10-19. The listed applicant is Myoworx, Inc.. The 510(k) number is K192746.
When did MyoWorx TM20 receive FDA 510(k) clearance?
MyoWorx TM20 received FDA 510(k) clearance on 2021-10-19, under 510(k) number K192746.
Who is the listed applicant for MyoWorx TM20?
The FDA 510(k) record lists Myoworx, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MyoWorx TM20?
The FDA product code for MyoWorx TM20 is IPF.
相關臨床試驗
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相關器械(代碼:IPF)
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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