FDA 510(k)

卡爾史托茲內視鏡成像系統

K 號：K212695 · 2021-11-15

決定日期2021-11-15

產品代碼OWN

諮詢委員會GU

決定相當於

器材摘要

KARL STORZ ICG Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America. It received FDA 510(k) clearance on 2021-11-15 under 510(k) number K212695. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KARL STORZ ICG Imaging System?

KARL STORZ ICG Imaging System is a medical device that received FDA 510(k) clearance on 2021-11-15. The listed applicant is Karl Storz Endoscopy America. The 510(k) number is K212695.

When did KARL STORZ ICG Imaging System receive FDA 510(k) clearance?

KARL STORZ ICG Imaging System received FDA 510(k) clearance on 2021-11-15, under 510(k) number K212695.

Who is the listed applicant for KARL STORZ ICG Imaging System?

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

What is the FDA product code for KARL STORZ ICG Imaging System?

The FDA product code for KARL STORZ ICG Imaging System is OWN.

其他以 Karl Storz Endoscopy America 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：OWN）

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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