FDA 510(k)

Reliance EPS內視鏡處理系統及Reliance DG乾燥消毒劑

K 號：K203223 · 2021-01-28

申請人Steris

決定日期2021-01-28

產品代碼NZA

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 Steris 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：NZA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K232918enspire 300系列自動內視鏡再處理器STERIS Corporation K230560enspire 300系列自動內視鏡再處理系統STERIS Corporation K220361Reliance EPS內視鏡處理系統及Reliance DG乾燥消毒劑STERIS Corporation K200989依賴式內視鏡處理系統STERIS Corporation

官方來源

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