S1：S1 注意：此回答中未包含任何公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符或URL的翻译，因为这些内容需要保持原样。
K 號：K231672 · 2023-10-13
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器材摘要
S1 is the device name listed in this FDA 510(k) record. The listed applicant is Medpark Co., Ltd.. It received FDA 510(k) clearance on 2023-10-13 under 510(k) number K231672. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the S1?
S1 is a medical device that received FDA 510(k) clearance on 2023-10-13. The listed applicant is Medpark Co., Ltd.. The 510(k) number is K231672.
When did S1 receive FDA 510(k) clearance?
S1 received FDA 510(k) clearance on 2023-10-13, under 510(k) number K231672.
Who is the listed applicant for S1?
The FDA 510(k) record lists Medpark Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for S1?
The FDA product code for S1 is NPM.
其他以 Medpark Co., Ltd. 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。
相關器械（代碼：NPM）
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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