ACIST RXi Mini 系統
K 號：K172216 · 2017-08-18
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器材摘要
ACIST RXi Mini System is the device name listed in this FDA 510(k) record. The listed applicant is Acist Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K172216. The device is classified under product code DRQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ACIST RXi Mini System?
ACIST RXi Mini System is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K172216.
When did ACIST RXi Mini System receive FDA 510(k) clearance?
ACIST RXi Mini System received FDA 510(k) clearance on 2017-08-18, under 510(k) number K172216.
Who is the listed applicant for ACIST RXi Mini System?
The FDA 510(k) record lists Acist Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ACIST RXi Mini System?
The FDA product code for ACIST RXi Mini System is DRQ.
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其他以 Acist Medical Systems, Inc. 為申請人之記錄
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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