SancDam 橡膠口罩 医療設備規範文本
K 號：K212037 · 2022-03-28
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決定日期2022-03-28
產品代碼MSC
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
SancDam Latex Oral Dam is the device name listed in this FDA 510(k) record. The listed applicant is Sanctuary Health Sdn. Bhd.. It received FDA 510(k) clearance on 2022-03-28 under 510(k) number K212037. The device is classified under product code MSC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SancDam Latex Oral Dam?
SancDam Latex Oral Dam is a medical device that received FDA 510(k) clearance on 2022-03-28. The listed applicant is Sanctuary Health Sdn. Bhd.. The 510(k) number is K212037.
When did SancDam Latex Oral Dam receive FDA 510(k) clearance?
SancDam Latex Oral Dam received FDA 510(k) clearance on 2022-03-28, under 510(k) number K212037.
Who is the listed applicant for SancDam Latex Oral Dam?
The FDA 510(k) record lists Sanctuary Health Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SancDam Latex Oral Dam?
The FDA product code for SancDam Latex Oral Dam is MSC.
相關臨床試驗
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相關器械（代碼：MSC）
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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