FDA 510(k)

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

K号: K203199 · 2020-12-01

决定日期2020-12-01

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, 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.

常见问题

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.

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 K200577RAS 12 搁架，RAS 12 长搁架，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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