FDA 510(k)

多功能平台系统（BL-M10）

K号: K240474 · 2024-05-20

申请人Shanghai Bele Medical Technology Co.,Ltd

决定日期2024-05-20

产品代码GEX

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决定实质等同

器械摘要

Multi-function Platform Systems (BL-M10) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Bele Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-05-20 under 510(k) number K240474. 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 Multi-function Platform Systems (BL-M10)?

Multi-function Platform Systems (BL-M10) is a medical device that received FDA 510(k) clearance on 2024-05-20. The listed applicant is Shanghai Bele Medical Technology Co.,Ltd. The 510(k) number is K240474.

When did Multi-function Platform Systems (BL-M10) receive FDA 510(k) clearance?

Multi-function Platform Systems (BL-M10) received FDA 510(k) clearance on 2024-05-20, under 510(k) number K240474.

Who is the listed applicant for Multi-function Platform Systems (BL-M10)?

The FDA 510(k) record lists Shanghai Bele Medical Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multi-function Platform Systems (BL-M10)?

The FDA product code for Multi-function Platform Systems (BL-M10) is GEX. This falls under the Gastroenterology category.

列明Shanghai Bele Medical Technology 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。

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官方来源

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