FDA 510(k)

RAS 12 擺放架 / RAS 12 長擺放架，用於AMSCO 7052HP / 7053HP單室清洗消毒器之RAS循環

K 號：K203199 · 2020-12-01

決定日期2020-12-01

產品代碼NVE

諮詢委員會GU

決定相當於

器材摘要

RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2020-12-01 under 510(k) number K203199. The device is classified under product code NVE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector?

RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector is a medical device that received FDA 510(k) clearance on 2020-12-01. The listed applicant is STERIS Corporation. The 510(k) number is K203199.

When did RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector receive FDA 510(k) clearance?

RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector received FDA 510(k) clearance on 2020-12-01, under 510(k) number K203199.

Who is the listed applicant for RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector?

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 RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector?

The FDA product code for RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector is NVE.

其他以 STERIS Corporation 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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相關器械（代碼：NVE）

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。

K222849AMSCO 600 鋰氣滅菌器，V-PRO maX 2 低溫滅菌系統，V-PRO s2 低溫滅菌系統，V-PRO 60 低溫滅菌系統，RAS 12 構架，RAS 12 長構架，AMSCO 7052HP 和 7053HP 单室滅菌清洗消毒器 RAS 循環Steris K222543AMSCO 600 蒸氣滅菌器, V-PRO maX 2 低溫滅菌系統, V-PRO s2 低溫滅菌系統, RAS 12 搬運架, RAS 12 長搬運架, AMSCO 7052HP 和 7053HP 单腔洗滅消毒器之 RAS 循環Steris K200577RAS 12 擺放架，RAS 12 長擺放架，AMSCO 7052HP/7053HP單室清洗/消毒器之RAS循環STERIS Corporation K190081RAS 12 擺放架，RAS 12 長擺放架；AMSCO 7052HP/7053HP單室清洗/消毒器之RAS循環STERIS Corporation

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