FDA 510(k)

enspire 300系列自動內視鏡再處理系統

K 號：K230560 · 2023-07-21

決定日期2023-07-21

產品代碼NZA

諮詢委員會GU

決定相當於

器材摘要

enspire 300 Series Automated Endoscope Reprocessor 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 2023-07-21 under 510(k) number K230560. 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 enspire 300 Series Automated Endoscope Reprocessor System?

enspire 300 Series Automated Endoscope Reprocessor System is a medical device that received FDA 510(k) clearance on 2023-07-21. The listed applicant is STERIS Corporation. The 510(k) number is K230560.

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

enspire 300 Series Automated Endoscope Reprocessor System received FDA 510(k) clearance on 2023-07-21, under 510(k) number K230560.

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

The FDA product code for enspire 300 Series Automated Endoscope Reprocessor System 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。

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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 K220361Reliance EPS內視鏡處理系統及Reliance DG乾燥消毒劑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

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