FDA 510(k)

Endoscope Reprocessor OER-Elite

K号: K201920 · 2020-09-01

决定日期2020-09-01

产品代码FEB

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决定实质等同

器械摘要

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.

常见问题

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)记录中列出Olympus Medical Systems Corp.为申请人。这本身并不足以确立该设备制造商的身份。

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

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

列明Olympus Medical Systems Corp.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K2620794K摄像头头 OLYMPUS CH-S700-08-LB K254056THUNDERBEAT 5 mm, 45 cm, 前驱动握把类型S (TB-0545FCS)；THUNDERBEAT 5 mm, 35 cm, 前驱动握把类型S (TB-0535FCS)；THUNDERBEAT 5 mm, 20 cm, 前驱动握把类型S (TB-0520FCS)K260580单次使用可重装夹子应用器（HX-810LR，HX-810UR）；夹子（HX-610-090，HX-610-135）；长夹子（HX-610-090L，HX-610-135L）；短夹子（HX-610-090S，HX-610-135S）；超短夹子（HX-610-135XS）K252341EVIS EXERA III 喉镜 (OLYMPUS BF-Q190); EVIS EXERA III 喉镜 (OLYMPUS BF-H190); EVIS EXERA III 喉镜 (OLYMPUS BF-1TH190)K251807一次性电外科止血镊 FD-410LR, FD-411UR, FD-412LR K253646一次性远端盖 MAJ-2315 (MAJ-2315)

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