FDA 510(k)

启辉3000清洗和液体化学灭菌处理系统

K号: K230930 · 2023-06-30

决定日期2023-06-30

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 Sterile 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 2023-06-30 under 510(k) number K230930. 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 Sterile Processing System?

enspire 3000 Cleaning and Liquid Chemical Sterile Processing System is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is STERIS Corporation. The 510(k) number is K230930.

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

enspire 3000 Cleaning and Liquid Chemical Sterile Processing System received FDA 510(k) clearance on 2023-06-30, under 510(k) number K230930.

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

The FDA product code for enspire 3000 Cleaning and Liquid Chemical Sterile 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。

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官方来源

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