CoreLite X光標本櫃
K 號：K193317 · 2019-12-13
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器材摘要
CoreLite X-Ray Specimen Cabinet is the device name listed in this FDA 510(k) record. The listed applicant is Cirdan Imaging Limited. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K193317. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CoreLite X-Ray Specimen Cabinet?
CoreLite X-Ray Specimen Cabinet is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Cirdan Imaging Limited. The 510(k) number is K193317.
When did CoreLite X-Ray Specimen Cabinet receive FDA 510(k) clearance?
CoreLite X-Ray Specimen Cabinet received FDA 510(k) clearance on 2019-12-13, under 510(k) number K193317.
Who is the listed applicant for CoreLite X-Ray Specimen Cabinet?
The FDA 510(k) record lists Cirdan Imaging Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CoreLite X-Ray Specimen Cabinet?
The FDA product code for CoreLite X-Ray Specimen Cabinet is MWP.
相關臨床試驗
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相關器械（代碼：MWP）
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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