FDA 510(k)

EVIS EXERA III 喉镜 (OLYMPUS BF-Q190); EVIS EXERA III 喉镜 (OLYMPUS BF-H190); EVIS EXERA III 喉镜 (OLYMPUS BF-1TH190)

K号: K252341 · 2026-04-23

决定日期2026-04-23

产品代码EOQ

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决定实质等同

器械摘要

EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) 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 2026-04-23 under 510(k) number K252341. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)?

EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) is a medical device that received FDA 510(k) clearance on 2026-04-23. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K252341.

When did EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) receive FDA 510(k) clearance?

EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) received FDA 510(k) clearance on 2026-04-23, under 510(k) number K252341.

Who is the listed applicant for EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)?

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 EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)?

The FDA product code for EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) is EOQ.

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）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)K251336VISERA ELITE III 视频系统中心奥林巴斯 OTV-S700（OTV-S700）；VISERA ELITE III 光源奥林巴斯 CLL-S700（CLL-S700）；4K 摄像头奥林巴斯 CH-S700-XZ-EA（CH-S700-XZ-EA）

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