DCM脊椎成形術系統
K 號：K162283 · 2017-02-06
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器材摘要
DCM Kyphoplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Dragon Crown Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-02-06 under 510(k) number K162283. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the DCM Kyphoplasty System?
DCM Kyphoplasty System is a medical device that received FDA 510(k) clearance on 2017-02-06. The listed applicant is Dragon Crown Medical Co., Ltd.. The 510(k) number is K162283.
When did DCM Kyphoplasty System receive FDA 510(k) clearance?
DCM Kyphoplasty System received FDA 510(k) clearance on 2017-02-06, under 510(k) number K162283.
Who is the listed applicant for DCM Kyphoplasty System?
The FDA 510(k) record lists Dragon Crown Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DCM Kyphoplasty System?
The FDA product code for DCM Kyphoplasty System is NDN.
相關臨床試驗
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相關器械（代碼：NDN）
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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