BEXCORE 乳癌切片系統，切片針
K 號：K171890 · 2018-08-20
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器材摘要
BEXCORE Breast Biopsy System, Biopsy Needle is the device name listed in this FDA 510(k) record. The listed applicant is Medical Park Co., Ltd.. It received FDA 510(k) clearance on 2018-08-20 under 510(k) number K171890. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BEXCORE Breast Biopsy System, Biopsy Needle?
BEXCORE Breast Biopsy System, Biopsy Needle is a medical device that received FDA 510(k) clearance on 2018-08-20. The listed applicant is Medical Park Co., Ltd.. The 510(k) number is K171890.
When did BEXCORE Breast Biopsy System, Biopsy Needle receive FDA 510(k) clearance?
BEXCORE Breast Biopsy System, Biopsy Needle received FDA 510(k) clearance on 2018-08-20, under 510(k) number K171890.
Who is the listed applicant for BEXCORE Breast Biopsy System, Biopsy Needle?
The FDA 510(k) record lists Medical Park Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BEXCORE Breast Biopsy System, Biopsy Needle?
The FDA product code for BEXCORE Breast Biopsy System, Biopsy Needle is KNW.
相關臨床試驗
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相關器械（代碼：KNW）
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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