FDA 510(k)

內視鏡LC

K 號：K232657 · 2023-09-01

決定日期2023-09-01

產品代碼EKX

諮詢委員會DE

決定相當於

器材摘要

InnerView LC is the device name listed in this FDA 510(k) record. The listed applicant is Perimetrics, Inc.. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K232657. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the InnerView LC?

InnerView LC is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Perimetrics, Inc.. The 510(k) number is K232657.

When did InnerView LC receive FDA 510(k) clearance?

InnerView LC received FDA 510(k) clearance on 2023-09-01, under 510(k) number K232657.

Who is the listed applicant for InnerView LC?

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

What is the FDA product code for InnerView LC?

The FDA product code for InnerView LC is EKX.

其他以 Perimetrics, Inc. 為申請人之記錄

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K251597內視系統

相關器械（代碼：EKX）

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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