FS-500DDR 醫療X光攝影系統
K 號：K152813 · 2016-12-02
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器材摘要
FS-500DDR Medical Radiographic X-Ray System is the device name listed in this FDA 510(k) record. The listed applicant is Orich Medical Equipment (Tianjin) Co., Ltd.. It received FDA 510(k) clearance on 2016-12-02 under 510(k) number K152813. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the FS-500DDR Medical Radiographic X-Ray System?
FS-500DDR Medical Radiographic X-Ray System is a medical device that received FDA 510(k) clearance on 2016-12-02. The listed applicant is Orich Medical Equipment (Tianjin) Co., Ltd.. The 510(k) number is K152813.
When did FS-500DDR Medical Radiographic X-Ray System receive FDA 510(k) clearance?
FS-500DDR Medical Radiographic X-Ray System received FDA 510(k) clearance on 2016-12-02, under 510(k) number K152813.
Who is the listed applicant for FS-500DDR Medical Radiographic X-Ray System?
The FDA 510(k) record lists Orich Medical Equipment (Tianjin) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FS-500DDR Medical Radiographic X-Ray System?
The FDA product code for FS-500DDR Medical Radiographic X-Ray System is KPR.
相關臨床試驗
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相關器械（代碼：KPR）
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
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