FDA 510(k)

启辉 300 系列自动内镜清洗消毒器

K号: K232918 · 2023-10-03

决定日期2023-10-03

产品代码NZA

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

enspire 300 Series Automated Endoscope Reprocessor is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2023-10-03 under 510(k) number K232918. The device is classified under product code NZA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the enspire 300 Series Automated Endoscope Reprocessor?

enspire 300 Series Automated Endoscope Reprocessor is a medical device that received FDA 510(k) clearance on 2023-10-03. The listed applicant is STERIS Corporation. The 510(k) number is K232918.

When did enspire 300 Series Automated Endoscope Reprocessor receive FDA 510(k) clearance?

enspire 300 Series Automated Endoscope Reprocessor received FDA 510(k) clearance on 2023-10-03, under 510(k) number K232918.

Who is the listed applicant for enspire 300 Series Automated Endoscope Reprocessor?

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 300 Series Automated Endoscope Reprocessor?

The FDA product code for enspire 300 Series Automated Endoscope Reprocessor is NZA.

列明STERIS Corporation为申报人的其他记录

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