FDA 510(k)

ENDOCAM Flex HD攝影系統 5521

K 號：K161204 · 2017-01-11

申請人Richard Wolf Medical Instruments Corporation

決定日期2017-01-11

產品代碼FET

諮詢委員會GU

決定相當於

器材摘要

ENDOCAM Flex HD Camera System 5521 is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corporation. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K161204. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ENDOCAM Flex HD Camera System 5521?

ENDOCAM Flex HD Camera System 5521 is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Richard Wolf Medical Instruments Corporation. The 510(k) number is K161204.

When did ENDOCAM Flex HD Camera System 5521 receive FDA 510(k) clearance?

ENDOCAM Flex HD Camera System 5521 received FDA 510(k) clearance on 2017-01-11, under 510(k) number K161204.

Who is the listed applicant for ENDOCAM Flex HD Camera System 5521?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOCAM Flex HD Camera System 5521?

The FDA product code for ENDOCAM Flex HD Camera System 5521 is FET.

其他以 Richard Wolf Medical Instruments Corporation 為申請人之記錄

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相關器械（代碼：FET）

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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