FDA 510(k)

Reliance EPS內視鏡處理系統及Reliance DG乾燥消毒劑

K 號：K220361 · 2022-03-10

決定日期2022-03-10

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 Corporation. It received FDA 510(k) clearance on 2022-03-10 under 510(k) number K220361. 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 2022-03-10. The listed applicant is STERIS Corporation. The 510(k) number is K220361.

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 2022-03-10, under 510(k) number K220361.

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

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 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 Corporation 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。

K261055AMSCO 700 鋰氣滅菌器 K260766Celerity 5 HP 生物指示標（LCB052）K251666系統1E 液體化學消毒劑處理系統，型號P6700；系統1內科液體化學消毒劑處理系統，型號P6900 K252680Celerity™ 20 HP 生物指示標 K251048Rapicide PA 高級消毒試紙模型參考編號 = ML02-0118 K243876驗證蒸汽整合指示器

查看所有 120 項裝置 →

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 K203223Reliance EPS內視鏡處理系統及Reliance DG乾燥消毒劑Steris K200989依賴式內視鏡處理系統STERIS Corporation

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。