FDA 510(k)

LFR-260

K 號：K233295 · 2024-05-31

決定日期2024-05-31

產品代碼SBI

諮詢委員會此為醫療器材法規文本之翻譯。根據醫療法規翻譯政策，以下為繁體中文譯文：本文件概述適用於醫療器材之監管架構，包括美國食品藥物管理局（FDA）之上市前審查程序。第510(k)條途徑適用於與已合法上市器材（predicate device）實質等效之器材，而上市前核准（PMA）則為最高風險等級（Class III）器材所要求。臨床證據可能引用NCT編號之試驗登記，或PMID編號之同行評審文獻。所有產品名稱、公司名稱、識別碼及統一資源定位符（URL）均保留原文，以確保可追溯性及法規提交之完整性。

決定相當於

器材摘要

LFR-260 is the device name listed in this FDA 510(k) record. The listed applicant is Evolution Optiks Limited. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K233295. The device is classified under product code SBI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LFR-260?

LFR-260 is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Evolution Optiks Limited. The 510(k) number is K233295.

When did LFR-260 receive FDA 510(k) clearance?

LFR-260 received FDA 510(k) clearance on 2024-05-31, under 510(k) number K233295.

Who is the listed applicant for LFR-260?

The FDA 510(k) record lists Evolution Optiks Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LFR-260?

The FDA product code for LFR-260 is SBI.

官方來源

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