SP-1000, SP-2000
K 號：K202395 · 2021-09-01
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器材摘要
SP-1000, SP-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Daesung Maref Co., Ltd.. It received FDA 510(k) clearance on 2021-09-01 under 510(k) number K202395. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SP-1000, SP-2000?
SP-1000, SP-2000 is a medical device that received FDA 510(k) clearance on 2021-09-01. The listed applicant is Daesung Maref Co., Ltd.. The 510(k) number is K202395.
When did SP-1000, SP-2000 receive FDA 510(k) clearance?
SP-1000, SP-2000 received FDA 510(k) clearance on 2021-09-01, under 510(k) number K202395.
Who is the listed applicant for SP-1000, SP-2000?
The FDA 510(k) record lists Daesung Maref Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SP-1000, SP-2000?
The FDA product code for SP-1000, SP-2000 is IRP.
其他以 Daesung Maref 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：IRP）
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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