Racz 神经调节射频发生器
K号: K232632 · 2024-05-24
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决定日期2024-05-24
产品代码GXD
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Racz Neurostat RF Generator is the device name listed in this FDA 510(k) record. The listed applicant is Epimed International. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K232632. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Racz Neurostat RF Generator?
Racz Neurostat RF Generator is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Epimed International. The 510(k) number is K232632.
When did Racz Neurostat RF Generator receive FDA 510(k) clearance?
Racz Neurostat RF Generator received FDA 510(k) clearance on 2024-05-24, under 510(k) number K232632.
Who is the listed applicant for Racz Neurostat RF Generator?
The FDA 510(k) record lists Epimed International as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Racz Neurostat RF Generator?
The FDA product code for Racz Neurostat RF Generator is GXD.
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。
相关器械（代码：GXD）
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。
K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)Boston Scientific Neuromodulation CorporationK242057COOLIEF* 射频发生器（CRG-BASIC，CRG-BASIC-R，CRG-ADVANCED，CRG-ADVANCED-R）Avanos Medical, Inc.K231675OneRF Ablation SystemNeuroone Medical Technologies Corp.K220122APEX 6Rf Innovations, Inc.K203293Abbott 医疗接地垫，型号 RF-DGP-ISABBOTT MEDICALK201610IonicRF发生器ABBOTT MEDICAL
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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