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FDA 510(k)

OMNIVision系統

K 號:K203751 · 2021-04-12

申請人Corin USA
決定日期2021-04-12
產品代碼OLO
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

OMNIVision system is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2021-04-12 under 510(k) number K203751. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OMNIVision system?

OMNIVision system is a medical device that received FDA 510(k) clearance on 2021-04-12. The listed applicant is Corin USA. The 510(k) number is K203751.

When did OMNIVision system receive FDA 510(k) clearance?

OMNIVision system received FDA 510(k) clearance on 2021-04-12, under 510(k) number K203751.

Who is the listed applicant for OMNIVision system?

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

What is the FDA product code for OMNIVision system?

The FDA product code for OMNIVision system is OLO.

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其他以 Corin USA 為申請人之記錄

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相關器械(代碼:OLO)

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。

官方來源

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