FDA 510(k)

PENTAX MEDICAL ED-3490TK，视频十二指肠镜

K号: K161222 · 2018-02-07

决定日期2018-02-07

产品代码FDT

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决定实质等同

器械摘要

PENTAX MEDICAL ED-3490TK, Video Duodenoscope is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Medical. It received FDA 510(k) clearance on 2018-02-07 under 510(k) number K161222. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PENTAX MEDICAL ED-3490TK, Video Duodenoscope?

PENTAX MEDICAL ED-3490TK, Video Duodenoscope is a medical device that received FDA 510(k) clearance on 2018-02-07. The listed applicant is Pentax Medical. The 510(k) number is K161222.

When did PENTAX MEDICAL ED-3490TK, Video Duodenoscope receive FDA 510(k) clearance?

PENTAX MEDICAL ED-3490TK, Video Duodenoscope received FDA 510(k) clearance on 2018-02-07, under 510(k) number K161222.

Who is the listed applicant for PENTAX MEDICAL ED-3490TK, Video Duodenoscope?

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

What is the FDA product code for PENTAX MEDICAL ED-3490TK, Video Duodenoscope?

The FDA product code for PENTAX MEDICAL ED-3490TK, Video Duodenoscope is FDT.

列明Pentax Medical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。

K192280PENTAX 医疗 ED-3490TK 视频十二指肠镜 K171011PENTAX 医疗 VIVIDEO 耳鼻喉视频内镜解决方案 K172156PENTAX 医疗 EPK-3000 视频成像系统 K163614PENTAX 医疗 ED34-i10T, 视频十二指肠镜

相关器械（代码：FDT）

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。

K251861富士胶片内窥镜型号ED-S100TP; 富士胶片内窥镜型号ED-S100XP; 富士胶片处理器型号VS-1000Fujifilm Corporation K253646一次性远端盖 MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp.K251867EVIS EXERA III 十二指肠镜 OLYMPUS TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K250701Evis Exera III十二指肠内窥镜Olympus TJF-Q190V（TJF-Q190V）Olympus Medical Systems Corp.K233942PENTAX 医疗视频十二指肠镜 (ED34-i10T2s)；PENTAX 医疗视频处理器 (EPK-i8020c)；PENTAX 医疗一次性，无菌远端帽带提升器 (OE-A63)；气/水供应阀门 (OF-B194 )Pentax of America, Inc.K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S

官方来源

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