FDA 510(k)

依賴式內視鏡處理系統

K 號：K200989 · 2020-05-14

決定日期2020-05-14

產品代碼NZA

諮詢委員會GU

決定相當於

器材摘要

Reliance Endoscope 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 2020-05-14 under 510(k) number K200989. 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 Endoscope Processing System?

Reliance Endoscope Processing System is a medical device that received FDA 510(k) clearance on 2020-05-14. The listed applicant is STERIS Corporation. The 510(k) number is K200989.

When did Reliance Endoscope Processing System receive FDA 510(k) clearance?

Reliance Endoscope Processing System received FDA 510(k) clearance on 2020-05-14, under 510(k) number K200989.

Who is the listed applicant for Reliance Endoscope 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 Reliance Endoscope Processing System?

The FDA product code for Reliance Endoscope Processing System is NZA.

其他以 STERIS Corporation 為申請人之記錄

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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。

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