FDA 510(k)

PENTAX 医疗视频食管镜 EE17-J10

K号: K223072 · 2022-12-02

决定日期2022-12-02

产品代码EOX

咨询委员会医疗设备监管文本描述翻译如下：关于[公司/产品名称]的监管信息： - 美国食品药品监督管理局（FDA）批准号：[510(k)编号] - 预市场批准（PMA）申请号：[PMA编号] - 临床试验注册号（NCT）：[NCT编号] - 医学文献标识符（PMID）：[PMID编号] - 产品标识符：[标识符] - 相关政策：医疗监管政策v1 - 更多信息请访问：[URL] 请注意，以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。

决定实质等同

器械摘要

PENTAX Medical Video Esophagoscope EE17-J10 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 2022-12-02 under 510(k) number K223072. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PENTAX Medical Video Esophagoscope EE17-J10?

PENTAX Medical Video Esophagoscope EE17-J10 is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Pentax of America, Inc.. The 510(k) number is K223072.

When did PENTAX Medical Video Esophagoscope EE17-J10 receive FDA 510(k) clearance?

PENTAX Medical Video Esophagoscope EE17-J10 received FDA 510(k) clearance on 2022-12-02, under 510(k) number K223072.

Who is the listed applicant for PENTAX Medical Video Esophagoscope EE17-J10?

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 Esophagoscope EE17-J10?

The FDA product code for PENTAX Medical Video Esophagoscope EE17-J10 is EOX.

列明Pentax of America, Inc.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。

K251256PENTAX 医疗视频上消化道镜 (EG 系列) (EG 系列)；PENTAX 医疗视频结肠镜 (EC 系列) (EC 系列)K251127PENTAX 医疗视频处理器 (EPK-i8020c)K242110PENTAX 医疗视频结肠镜 (EC38-i20cWL)K241213PENTAX 医疗视频上消化道镜 (EG27-i20c)；PENTAX 医疗视频结肠镜 (EC34-i20cL)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 )K240457C2 冷冻球囊消融系统（C2 冷冻球囊消融系统）

查看所有 39 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。