The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] 2019.02.18 The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Tweet Share Hatena Pocket RSS feedly Pin it FDA 510(k)関連 レビュと承認について 内部監査について 関連記事一覧 FDA 510(k)申請審査の厳格化とS/Wの信頼性保証について 2019.01.13 Refuse to Accept Policy for 510(k)s 2019.02.18 FDA 510(k)申請とは 2021.09.20 Guidance for the Content of Premarket Submissions f... 2019.02.18