INVOcell 阴道內培養系統
K 號：K222932 · 2023-06-22
廣告
決定日期2023-06-22
產品代碼OYO
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
INVOcell Intravaginal Culture System is the device name listed in this FDA 510(k) record. The listed applicant is Invo Bioscience. It received FDA 510(k) clearance on 2023-06-22 under 510(k) number K222932. The device is classified under product code OYO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the INVOcell Intravaginal Culture System?
INVOcell Intravaginal Culture System is a medical device that received FDA 510(k) clearance on 2023-06-22. The listed applicant is Invo Bioscience. The 510(k) number is K222932.
When did INVOcell Intravaginal Culture System receive FDA 510(k) clearance?
INVOcell Intravaginal Culture System received FDA 510(k) clearance on 2023-06-22, under 510(k) number K222932.
Who is the listed applicant for INVOcell Intravaginal Culture System?
The FDA 510(k) record lists Invo Bioscience as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for INVOcell Intravaginal Culture System?
The FDA product code for INVOcell Intravaginal Culture System is OYO.
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官方來源
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