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K 號:K170985 · 2017-09-25
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器材摘要
Urbanek Device is the device name listed in this FDA 510(k) record. The listed applicant is Tmj Services, LLC. It received FDA 510(k) clearance on 2017-09-25 under 510(k) number K170985. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.
常見問題
What is the Urbanek Device?
Urbanek Device is a medical device that received FDA 510(k) clearance on 2017-09-25. The listed applicant is Tmj Services, LLC. The 510(k) number is K170985.
When did Urbanek Device receive FDA 510(k) clearance?
Urbanek Device received FDA 510(k) clearance on 2017-09-25, under 510(k) number K170985.
Who is the listed applicant for Urbanek Device?
The FDA 510(k) record lists Tmj Services, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Urbanek Device?
The FDA product code for Urbanek Device is MQC.
相關臨床試驗
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相關器械(代碼:MQC)
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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