FDA 510(k)SYSTEM 1E Liquid Chemical Sterilant Processing System
K 號：K161683 · 2016-08-05
決定日期2016-08-05
產品代碼MED
諮詢委員會HO
決定Substantially Equivalent
器材摘要
SYSTEM 1E Liquid Chemical Sterilant Processing System is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2016-08-05 under 510(k) number K161683. The device is classified under product code MED. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SYSTEM 1E Liquid Chemical Sterilant Processing System?
SYSTEM 1E Liquid Chemical Sterilant Processing System is a medical device that received FDA 510(k) clearance on 2016-08-05. The listed applicant is STERIS Corporation. The 510(k) number is K161683.
When did SYSTEM 1E Liquid Chemical Sterilant Processing System receive FDA 510(k) clearance?
SYSTEM 1E Liquid Chemical Sterilant Processing System received FDA 510(k) clearance on 2016-08-05, under 510(k) number K161683.
Who is the listed applicant for SYSTEM 1E Liquid Chemical Sterilant Processing System?
The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SYSTEM 1E Liquid Chemical Sterilant Processing System?
The FDA product code for SYSTEM 1E Liquid Chemical Sterilant Processing System is MED.
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其他以 STERIS Corporation 為申請人之記錄
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相關器械（代碼：MED）
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。
K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900STERIS CorporationK232914SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)STERIS CorporationK230582SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900STERIS CorporationK222615SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant ConcentrateSTERIS CorporationK211607SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant ConcentrateSTERIS CorporationK210737SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant ConcentrateSTERIS Corporation