FDA 510(k)

Reliance EPS 内窥镜处理系统及 Reliance DG 干燥消毒剂

K号: K203223 · 2021-01-28

申请人Steris

决定日期2021-01-28

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

Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide is the device name listed in this FDA 510(k) record. The listed applicant is Steris. It received FDA 510(k) clearance on 2021-01-28 under 510(k) number K203223. 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 Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide?

Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide is a medical device that received FDA 510(k) clearance on 2021-01-28. The listed applicant is Steris. The 510(k) number is K203223.

When did Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide receive FDA 510(k) clearance?

Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide received FDA 510(k) clearance on 2021-01-28, under 510(k) number K203223.

Who is the listed applicant for Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide?

The FDA 510(k) record lists Steris as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide?

The FDA product code for Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide is NZA.

列明Steris为申报人的其他记录

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官方来源

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