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FDA 510(k)

Q 脉冲激光机 (QNHF-01)

K号: K242943 · 2025-03-03

决定日期2025-03-03
产品代码GEX
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Q Switched Nd:YAG Laser machine (QNHF-01) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Nubway S&T Co., Ltd.. It received FDA 510(k) clearance on 2025-03-03 under 510(k) number K242943. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the Q Switched Nd:YAG Laser machine (QNHF-01)?

Q Switched Nd:YAG Laser machine (QNHF-01) is a medical device that received FDA 510(k) clearance on 2025-03-03. The listed applicant is Beijing Nubway S&T Co., Ltd.. The 510(k) number is K242943.

When did Q Switched Nd:YAG Laser machine (QNHF-01) receive FDA 510(k) clearance?

Q Switched Nd:YAG Laser machine (QNHF-01) received FDA 510(k) clearance on 2025-03-03, under 510(k) number K242943.

Who is the listed applicant for Q Switched Nd:YAG Laser machine (QNHF-01)?

FDA 510(k)记录将北京纽贝威科技有限公司列为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Q Switched Nd:YAG Laser machine (QNHF-01)?

The FDA product code for Q Switched Nd:YAG Laser machine (QNHF-01) is GEX. This falls under the Gastroenterology category.

相关临床试验

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。

列明Beijing Nubway S&T Co., Ltd.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。

相关器械(代码:GEX)

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。

官方来源

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