FDA 510(k)

TrueTear 鼻腔淚液神經刺激器

K 號：K193589 · 2020-08-31

決定日期2020-08-31

產品代碼QBR

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

TrueTear Intranasal Tear Neurostimulator is the device name listed in this FDA 510(k) record. The listed applicant is Allergan. It received FDA 510(k) clearance on 2020-08-31 under 510(k) number K193589. The device is classified under product code QBR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TrueTear Intranasal Tear Neurostimulator?

TrueTear Intranasal Tear Neurostimulator is a medical device that received FDA 510(k) clearance on 2020-08-31. The listed applicant is Allergan. The 510(k) number is K193589.

When did TrueTear Intranasal Tear Neurostimulator receive FDA 510(k) clearance?

TrueTear Intranasal Tear Neurostimulator received FDA 510(k) clearance on 2020-08-31, under 510(k) number K193589.

Who is the listed applicant for TrueTear Intranasal Tear Neurostimulator?

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

What is the FDA product code for TrueTear Intranasal Tear Neurostimulator?

The FDA product code for TrueTear Intranasal Tear Neurostimulator is QBR.

其他以 Allergan 為申請人之記錄

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器材摘要

常見問題

相關臨床試驗

其他以 Allergan 為申請人之記錄

官方來源