FDA 510(k)

Optina-4C (MHRC-C1N)

K 號：K250770 · 2025-09-04

決定日期2025-09-04

產品代碼HKI

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

Optina-4C (MHRC-C1N) is the device name listed in this FDA 510(k) record. The listed applicant is Optina Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K250770. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Optina-4C (MHRC-C1N)?

Optina-4C (MHRC-C1N) is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Optina Diagnostics, Inc.. The 510(k) number is K250770.

When did Optina-4C (MHRC-C1N) receive FDA 510(k) clearance?

Optina-4C (MHRC-C1N) received FDA 510(k) clearance on 2025-09-04, under 510(k) number K250770.

Who is the listed applicant for Optina-4C (MHRC-C1N)?

The FDA 510(k) record lists Optina Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optina-4C (MHRC-C1N)?

The FDA product code for Optina-4C (MHRC-C1N) is HKI.

其他以 Optina Diagnostics, Inc. 為申請人之記錄

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K231230Optina-4C (MHRC-C1N)

相關器械（代碼：HKI）

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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