FDA 510(k)

內視鏡再處理器 OER-Elite

K 號：K201920 · 2020-09-01

決定日期2020-09-01

產品代碼FEB

諮詢委員會GU

決定相當於

器材摘要

Endoscope Reprocessor OER-Elite is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2020-09-01 under 510(k) number K201920. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Endoscope Reprocessor OER-Elite?

Endoscope Reprocessor OER-Elite is a medical device that received FDA 510(k) clearance on 2020-09-01. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K201920.

When did Endoscope Reprocessor OER-Elite receive FDA 510(k) clearance?

Endoscope Reprocessor OER-Elite received FDA 510(k) clearance on 2020-09-01, under 510(k) number K201920.

Who is the listed applicant for Endoscope Reprocessor OER-Elite?

FDA 510(k) 記錄將Olympus Medical Systems Corp. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Endoscope Reprocessor OER-Elite?

The FDA product code for Endoscope Reprocessor OER-Elite is FEB.

其他以 Olympus Medical Systems Corp. 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。

K2620794K攝影鏡頭 OLYMPUS CH-S700-08-LB 医療設備規範文本 K254056THUNDERBEAT 5 mm, 45 cm, 前動握把型 S (TB-0545FCS)；THUNDERBEAT 5 mm, 35 cm, 前動握把型 S (TB-0535FCS)；THUNDERBEAT 5 mm, 20 cm, 前動握把型 S (TB-0520FCS)K260580單次使用可重裝夾釘應用器（HX-810LR，HX-810UR）；夾釘（HX-610-090，HX-610-135）；長夾釘（HX-610-090L，HX-610-135L）；短夾釘（HX-610-090S，HX-610-135S）；超短夾釘（HX-610-135XS）K252341EVIS EXERA III 支气管內視鏡 (OLYMPUS BF-Q190)；EVIS EXERA III 支气管內視鏡 (OLYMPUS BF-H190)；EVIS EXERA III 支气管內視鏡 (OLYMPUS BF-1TH190)K251807單次使用電外科止血鉗 FD-410LR, FD-411UR, FD-412LR K253646單次使用遠端蓋 MAJ-2315 (MAJ-2315)

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相關器械（代碼：FEB）

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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