FDA 510(k)

ORIGIO®處理™不含酚紅（品號 8310），ORIGIO®處理™含酚紅（品號 8311）

K 號：K173624 · 2018-03-02

決定日期2018-03-02

產品代碼MQL

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311) is the device name listed in this FDA 510(k) record. The listed applicant is Origio A/S. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K173624. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)?

ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311) is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Origio A/S. The 510(k) number is K173624.

When did ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311) receive FDA 510(k) clearance?

ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311) received FDA 510(k) clearance on 2018-03-02, under 510(k) number K173624.

Who is the listed applicant for ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)?

The FDA 510(k) record lists Origio A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)?

The FDA product code for ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311) is MQL.

其他以 Origio A/S 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：MQL）

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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