FDA 510(k)

PENTAX 電子內視鏡上消化道內視鏡 EG34-i10

K 號：K180292 · 2018-10-12

決定日期2018-10-12

產品代碼FDS

諮詢委員會GU

決定相當於

器材摘要

PENTAX Video Upper G.I. Scope EG34-i10 is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Medical of America, Inc.. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K180292. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PENTAX Video Upper G.I. Scope EG34-i10?

PENTAX Video Upper G.I. Scope EG34-i10 is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Pentax Medical of America, Inc.. The 510(k) number is K180292.

When did PENTAX Video Upper G.I. Scope EG34-i10 receive FDA 510(k) clearance?

PENTAX Video Upper G.I. Scope EG34-i10 received FDA 510(k) clearance on 2018-10-12, under 510(k) number K180292.

Who is the listed applicant for PENTAX Video Upper G.I. Scope EG34-i10?

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

What is the FDA product code for PENTAX Video Upper G.I. Scope EG34-i10?

The FDA product code for PENTAX Video Upper G.I. Scope EG34-i10 is FDS.

其他以 Pentax Medical of America, Inc. 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。

K180285PENTAX醫療內視鏡電腦顯示結腸鏡EC34-i10T系列

相關器械（代碼：FDS）

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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