FDA 510(k)

SMB Luer lock 一次性針筒

K 號：K231558 · 2024-01-12

決定日期2024-01-12

產品代碼FMF

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

SMB Luer lock disposable syringe is the device name listed in this FDA 510(k) record. The listed applicant is Smb Corporation of India. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K231558. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SMB Luer lock disposable syringe?

SMB Luer lock disposable syringe is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Smb Corporation of India. The 510(k) number is K231558.

When did SMB Luer lock disposable syringe receive FDA 510(k) clearance?

SMB Luer lock disposable syringe received FDA 510(k) clearance on 2024-01-12, under 510(k) number K231558.

Who is the listed applicant for SMB Luer lock disposable syringe?

The FDA 510(k) record lists Smb Corporation of India as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMB Luer lock disposable syringe?

The FDA product code for SMB Luer lock disposable syringe is FMF.

相關器械（代碼：FMF）

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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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：FMF）

官方來源