FDA 510(k)

PENTAX醫療EPK-i7010及PENTAX EPK-i5010內視鏡處理器，屬於GI系列

K 號：K191282 · 2019-11-08

決定日期2019-11-08

產品代碼PEA

諮詢委員會GU

決定相當於

器材摘要

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2019-11-08 under 510(k) number K191282. The device is classified under product code PEA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family?

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Pentax of America, Inc.. The 510(k) number is K191282.

When did PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family receive FDA 510(k) clearance?

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family received FDA 510(k) clearance on 2019-11-08, under 510(k) number K191282.

Who is the listed applicant for PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family?

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

What is the FDA product code for PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family?

The FDA product code for PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family is PEA.

其他以 Pentax 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。

K251256PENTAX醫療內視鏡上消化道內視鏡（EG系列）（EG系列）；PENTAX醫療內視鏡結腸內視鏡（EC系列）（EC系列）K251127PENTAX醫療影片處理器（EPK-i8020c）K242110PENTAX醫療內視鏡視頻結腸鏡（EC38-i20cWL）K241213PENTAX醫療內視鏡上消化道內視鏡（EG27-i20c）；PENTAX醫療內視鏡結腸內視鏡（EC34-i20cL）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）K240457C2 冷氣球消融系統（C2 冷氣球消融系統）

查看所有 39 項裝置 →

相關器械（代碼：PEA）

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。

K251127PENTAX醫療影片處理器（EPK-i8020c）Pentax of America, Inc.K231249PENTAX醫療影片處理器EPK-i8020c，PENTAX醫療影片上消化道內視鏡EG29-i20c，PENTAX醫療影片大腸內視鏡EC38-i20cLPentax of America, Inc.K190805PENTAX醫療影片處理器EPK-i5500c，PENTAX醫療影片上消化道內視鏡EG29-i10c，PENTAX醫療影片大腸內視鏡EC34-i10cL，PENTAX醫療影片大腸內視鏡EC38-i10cLPentax of America, Inc.K173679PENTAX醫療EPK-i7010影片處理器，配EB系列鏡頭Pentax of America, Inc.K160275融合內視鏡系統搭配FuseBox處理器Endochoice, Inc.

官方來源

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