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FDA 510(k)

Multi-function Platform Systems (BL-M10)

K-Number: K240474 · 2024-05-20

ApplicantShanghai Bele Medical Technology Co.,Ltd
Decision Date2024-05-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Multi-function Platform Systems (BL-M10) is a medical device manufactured by Shanghai Bele Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-05-20 under approval 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.

Frequently Asked Questions

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. It is manufactured by Shanghai Bele Medical Technology Co.,Ltd. The 510(k) number is K240474.

When was Multi-function Platform Systems (BL-M10) approved by the FDA?

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

What company makes Multi-function Platform Systems (BL-M10)?

Multi-function Platform Systems (BL-M10) is manufactured by Shanghai Bele Medical Technology Co.,Ltd.

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.

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Related PubMed Literature

PMID: 42212181 Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework. Journal of multidisciplinary healthcare (2026) PMID: 41810241 Diverging regulatory DNA in adaptive medical AI: US agility and EU accountability in lifecycle governance. Frontiers in medicine (2026) PMID: 40965839 A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest. Journal of pediatric endocrinology & metabolism : JPEM (2025) PMID: 40623156 Legal and regulatory challenges in multi-country data-driven projects developing and validating medical AI systems in the EU. Expert review of medical devices (2025)

Other Devices by Shanghai Bele Medical Technology Co.,Ltd

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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