FDA 510(k)

卡迪那爾健康NPWT灌洗管路組，卡迪那爾健康NPWT灌洗輸送組

K 號：K161418 · 2017-01-19

決定日期2017-01-19

產品代碼OMP

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K161418. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set?

Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Cardinalhealth. The 510(k) number is K161418.

When did Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set receive FDA 510(k) clearance?

Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set received FDA 510(k) clearance on 2017-01-19, under 510(k) number K161418.

Who is the listed applicant for Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set?

FDA 510(k) 記錄將 Cardinalhealth 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set?

The FDA product code for Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set is OMP.

其他以 Cardinalhealth 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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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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