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FDA 510(k)

Cenorin 610清潔-過濾滅菌器/高級消毒器及Cenorin 610HT清潔-過濾滅菌器/高級消毒器

K 號：K183444 · 2019-09-09

申請人Cenorin, LLC
決定日期2019-09-09
產品代碼LDS
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

Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector is the device name listed in this FDA 510(k) record. The listed applicant is Cenorin, LLC. It received FDA 510(k) clearance on 2019-09-09 under 510(k) number K183444. The device is classified under product code LDS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector?

Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector is a medical device that received FDA 510(k) clearance on 2019-09-09. The listed applicant is Cenorin, LLC. The 510(k) number is K183444.

When did Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector receive FDA 510(k) clearance?

Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector received FDA 510(k) clearance on 2019-09-09, under 510(k) number K183444.

Who is the listed applicant for Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector?

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

What is the FDA product code for Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector?

The FDA product code for Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector is LDS.

相關臨床試驗

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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