FDA 510(k)

EVA，前方機器，EVA，合併機器，EVA合併機器配雷射（DORC接頭），EVA合併機器配雷射（SMA接頭）

K 號：K190875 · 2019-09-25

申請人D.O.R.C. Dutch Ophthalmic Research Center (International)

決定日期2019-09-25

產品代碼HQC

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

EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) is the device name listed in this FDA 510(k) record. The listed applicant is D.O.R.C. Dutch Ophthalmic Research Center (International). It received FDA 510(k) clearance on 2019-09-25 under 510(k) number K190875. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)?

EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) is a medical device that received FDA 510(k) clearance on 2019-09-25. The listed applicant is D.O.R.C. Dutch Ophthalmic Research Center (International). The 510(k) number is K190875.

When did EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) receive FDA 510(k) clearance?

EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) received FDA 510(k) clearance on 2019-09-25, under 510(k) number K190875.

Who is the listed applicant for EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)?

The FDA 510(k) record lists D.O.R.C. Dutch Ophthalmic Research Center (International) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)?

The FDA product code for EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) is HQC.

其他以 D.O.R.C. Dutch Ophthalmic Research Center (International) 為申請人之記錄

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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相關器械（代碼：HQC）

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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