16ch 足/踝 SPEEDER
K 號：K181697 · 2018-07-11
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器材摘要
16ch Foot/ Ankle SPEEDER is the device name listed in this FDA 510(k) record. The listed applicant is Quality Electrodynamics, LLC. It received FDA 510(k) clearance on 2018-07-11 under 510(k) number K181697. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the 16ch Foot/ Ankle SPEEDER?
16ch Foot/ Ankle SPEEDER is a medical device that received FDA 510(k) clearance on 2018-07-11. The listed applicant is Quality Electrodynamics, LLC. The 510(k) number is K181697.
When did 16ch Foot/ Ankle SPEEDER receive FDA 510(k) clearance?
16ch Foot/ Ankle SPEEDER received FDA 510(k) clearance on 2018-07-11, under 510(k) number K181697.
Who is the listed applicant for 16ch Foot/ Ankle SPEEDER?
The FDA 510(k) record lists Quality Electrodynamics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 16ch Foot/ Ankle SPEEDER?
The FDA product code for 16ch Foot/ Ankle SPEEDER is MOS.
相關臨床試驗
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其他以 Quality Electrodynamics, LLC 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。
相關器械（代碼：MOS）
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。
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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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