UDE
K号: K202292 · 2020-10-05
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器械摘要
UDE is the device name listed in this FDA 510(k) record. The listed applicant is Ebm Technologies, Inc.. It received FDA 510(k) clearance on 2020-10-05 under 510(k) number K202292. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the UDE?
UDE is a medical device that received FDA 510(k) clearance on 2020-10-05. The listed applicant is Ebm Technologies, Inc.. The 510(k) number is K202292.
When did UDE receive FDA 510(k) clearance?
UDE received FDA 510(k) clearance on 2020-10-05, under 510(k) number K202292.
Who is the listed applicant for UDE?
The FDA 510(k) record lists Ebm Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UDE?
The FDA product code for UDE is LLZ.
相关 PubMed 文献
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。
PMID：42566800排除FDA人道主义设备豁免的年轻儿童深部脑刺激的安全性、可行性和结果：CHILD-DBS登记册分析。Journal of neurosurgery. Pediatrics ()PMID：42174919基于软件的医疗器械安全监测自动化：FDA MAUDE 数据的见解。Studies in health technology and informatics ()PMID：41938148EUS引起的设备故障和患者不良事件：26年FDA MAUDE分析（2000-2025）Endoscopic ultrasound ()PMID：40854178Health Professional Students' Knowledge About FDA Drug and Medical Device Regulation.Academic medicine : journal of the Association of American Medical Colleges ()
相关器械（代码：LLZ）
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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请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。Taiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC
官方来源
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