FDA 510(k)

PENTAX醫療 ED34-i10T, 電子十二指腸鏡

K 號：K163614 · 2017-09-20

決定日期2017-09-20

產品代碼FDT

諮詢委員會GU

決定相當於

器材摘要

PENTAX Medical ED34-i10T, Video Duodenoscope is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Medical. It received FDA 510(k) clearance on 2017-09-20 under 510(k) number K163614. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PENTAX Medical ED34-i10T, Video Duodenoscope?

PENTAX Medical ED34-i10T, Video Duodenoscope is a medical device that received FDA 510(k) clearance on 2017-09-20. The listed applicant is Pentax Medical. The 510(k) number is K163614.

When did PENTAX Medical ED34-i10T, Video Duodenoscope receive FDA 510(k) clearance?

PENTAX Medical ED34-i10T, Video Duodenoscope received FDA 510(k) clearance on 2017-09-20, under 510(k) number K163614.

Who is the listed applicant for PENTAX Medical ED34-i10T, Video Duodenoscope?

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

What is the FDA product code for PENTAX Medical ED34-i10T, Video Duodenoscope?

The FDA product code for PENTAX Medical ED34-i10T, Video Duodenoscope is FDT.

其他以 Pentax Medical 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。

K192280PENTAX醫療 ED-3490TK 電子十二指腸鏡 K171011PENTAX醫療 VIVIDEO ENT 頻道式內視鏡解決方案 K172156PENTAX醫療EPK-3000影片成像系統 K161222PENTAX醫療 ED-3490TK, 電子十二指腸鏡

相關器械（代碼：FDT）

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。

K251861富士通內視鏡型號 ED-S100TP；富士通內視鏡型號 ED-S100XP；富士通處理器型號 VS-1000Fujifilm Corporation K253646單次使用遠端蓋 MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp.K251867EVIS EXERA III 十二指腸內視鏡奧林巴斯 TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K250701Evis Exera III 十二指腸內視鏡奧林巴斯 TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K233942PENTAX醫療內視鏡攝影十二指腸內視鏡（ED34-i10T2s）；PENTAX醫療內視鏡處理器（EPK-i8020c）；PENTAX醫療一次性、无菌遠端蓋子帶提升器（OE-A63）；氣/水供給閥（OF-B194）Pentax of America, Inc.K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S

官方來源

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