NeoNavia 結石系統
K 號：K220595 · 2022-09-08
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器材摘要
NeoNavia Biopsy System is the device name listed in this FDA 510(k) record. The listed applicant is Neodynamics AB. It received FDA 510(k) clearance on 2022-09-08 under 510(k) number K220595. 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 NeoNavia Biopsy System?
NeoNavia Biopsy System is a medical device that received FDA 510(k) clearance on 2022-09-08. The listed applicant is Neodynamics AB. The 510(k) number is K220595.
When did NeoNavia Biopsy System receive FDA 510(k) clearance?
NeoNavia Biopsy System received FDA 510(k) clearance on 2022-09-08, under 510(k) number K220595.
Who is the listed applicant for NeoNavia Biopsy System?
The FDA 510(k) record lists Neodynamics AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NeoNavia Biopsy System?
The FDA product code for NeoNavia Biopsy System 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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