FDA 510(k)

启辉3000清洗和液体化学灭菌剂处理系统

K号: K243433 · 2024-12-02

决定日期2024-12-02

产品代码FEB

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决定实质等同

器械摘要

enspire 3000 Cleaning and 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 2024-12-02 under 510(k) number K243433. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System?

enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System is a medical device that received FDA 510(k) clearance on 2024-12-02. The listed applicant is STERIS Corporation. The 510(k) number is K243433.

When did enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System receive FDA 510(k) clearance?

enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System received FDA 510(k) clearance on 2024-12-02, under 510(k) number K243433.

Who is the listed applicant for enspire 3000 Cleaning and 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 enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System?

The FDA product code for enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System is FEB.

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

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官方来源

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