FDA 510(k)

PENTAX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）

K 號：K241213 · 2024-12-06

決定日期2024-12-06

產品代碼FDS

諮詢委員會GU

決定相當於

器材摘要

PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) 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 2024-12-06 under 510(k) number K241213. 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 Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)?

PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Pentax of America, Inc.. The 510(k) number is K241213.

When did PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) receive FDA 510(k) clearance?

PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) received FDA 510(k) clearance on 2024-12-06, under 510(k) number K241213.

Who is the listed applicant for PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)?

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 Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)?

The FDA product code for PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) is FDS.

其他以 Pentax of America, Inc. 為申請人之記錄

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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）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）K232860PENTAX醫療影片處理器EPK-i8020c，PENTAX醫療影片支氣管內鏡EB11-J10，PENTAX醫療影片支氣管內鏡EB15-J10，PENTAX醫療影片支氣管內鏡EB19-J10U，PENTAX醫療超聲波影片支氣管內鏡EB19-J10U

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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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