FDA 510(k)

RAS 12 搁架，RAS 12 长搁架，AMSCO 7052HP/7053HP 单室清洗消毒器 RAS 循环

K号: K200577 · 2020-04-03

决定日期2020-04-03

产品代码NVE

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决定实质等同

器械摘要

RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the 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 2020-04-03 under 510(k) number K200577. The device is classified under product code NVE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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

RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector is a medical device that received FDA 510(k) clearance on 2020-04-03. The listed applicant is STERIS Corporation. The 510(k) number is K200577.

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

RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector received FDA 510(k) clearance on 2020-04-03, under 510(k) number K200577.

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

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

列明STERIS Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261055AMSCO 700 蒸汽灭菌器 K260766Celerity 5 HP 生物指示剂（LCB052）K251666SYSTEM 1E 液体化学灭菌剂处理系统，型号 P6700；SYSTEM 1 内窥镜液体化学灭菌剂处理系统，型号 P6900 K252680Celerity™ 20 HP 生物指示剂 K251048Rapicide PA 高级消毒测试条模型参考号 = ML02-0118 K243876验证蒸汽集成指示器

查看所有 120 个设备 →

相关器械（代码：NVE）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K222849AMSCO 600 蒸汽灭菌器，V-PRO maX 2 低温灭菌系统，V-PRO s2 低温灭菌系统，V-PRO 60 低温灭菌系统，RAS 12 载架，RAS 12 长载架，AMSCO 7052HP 和 7053HP 单室清洗消毒器 RAS 循环Steris K222543AMSCO 600 蒸汽灭菌器，V-PRO maX 2 低温灭菌系统，V-PRO s2 低温灭菌系统，RAS 12 载架，RAS 12 长载架，AMSCO 7052HP 和 7053HP 单室清洗消毒器 RAS 循环Steris K203199RAS 12 搁架 / RAS 12 长搁架，用于AMSCO 7052HP / 7053HP 单室清洗消毒器 RAS 循环STERIS Corporation K190081RAS 12 搁架，RAS 12 长搁架；AMSCO 7052HP/7053HP 单室清洗消毒器 RAS 循环STERIS Corporation

官方来源

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