FDA 510(k)

PRIMUS醫療設備消毒器（型號PSS11-HC）

K 號：K221474 · 2023-02-10

決定日期2023-02-10

產品代碼FLE

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

PRIMUS Healthcare Sterilizer (Model PSS11-HC) is the device name listed in this FDA 510(k) record. The listed applicant is Primus Sterilizer Company, LLC. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K221474. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PRIMUS Healthcare Sterilizer (Model PSS11-HC)?

PRIMUS Healthcare Sterilizer (Model PSS11-HC) is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Primus Sterilizer Company, LLC. The 510(k) number is K221474.

When did PRIMUS Healthcare Sterilizer (Model PSS11-HC) receive FDA 510(k) clearance?

PRIMUS Healthcare Sterilizer (Model PSS11-HC) received FDA 510(k) clearance on 2023-02-10, under 510(k) number K221474.

Who is the listed applicant for PRIMUS Healthcare Sterilizer (Model PSS11-HC)?

The FDA 510(k) record lists Primus Sterilizer Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMUS Healthcare Sterilizer (Model PSS11-HC)?

The FDA product code for PRIMUS Healthcare Sterilizer (Model PSS11-HC) is FLE.

其他以 Primus Sterilizer Company, LLC 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。

K233132PRIMUS醫療設備消毒器（型號PSS11-HA及PSS11-HB）

相關器械（代碼：FLE）

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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官方來源

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