FDA 510(k)

多功能平台系統 (BL-M10)

K 號：K240474 · 2024-05-20

申請人Shanghai Bele Medical Technology Co.,Ltd

決定日期2024-05-20

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Shanghai Bele Medical Technology Co.,Ltd 為申請人之記錄

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官方來源

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