SG Lanset I，SG Lancets，柔軟針頭
K 號：K230712 · 2023-12-06
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器材摘要
SG Lanset I, SG Lancets, Soft Lancets is the device name listed in this FDA 510(k) record. The listed applicant is Sewon Medical Co.. It received FDA 510(k) clearance on 2023-12-06 under 510(k) number K230712. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SG Lanset I, SG Lancets, Soft Lancets?
SG Lanset I, SG Lancets, Soft Lancets is a medical device that received FDA 510(k) clearance on 2023-12-06. The listed applicant is Sewon Medical Co.. The 510(k) number is K230712.
When did SG Lanset I, SG Lancets, Soft Lancets receive FDA 510(k) clearance?
SG Lanset I, SG Lancets, Soft Lancets received FDA 510(k) clearance on 2023-12-06, under 510(k) number K230712.
Who is the listed applicant for SG Lanset I, SG Lancets, Soft Lancets?
The FDA 510(k) record lists Sewon Medical Co. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SG Lanset I, SG Lancets, Soft Lancets?
The FDA product code for SG Lanset I, SG Lancets, Soft Lancets is QRK.
相關臨床試驗
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相關器械（代碼：QRK）
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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