FDA 510(k)

OneRF Ablation System

K号: K231675 · 2023-12-06

决定日期2023-12-06

产品代码GXD

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决定实质等同

器械摘要

OneRF Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Neuroone Medical Technologies Corp.. It received FDA 510(k) clearance on 2023-12-06 under 510(k) number K231675. 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 OneRF Ablation System?

OneRF Ablation System is a medical device that received FDA 510(k) clearance on 2023-12-06. The listed applicant is Neuroone Medical Technologies Corp.. The 510(k) number is K231675.

When did OneRF Ablation System receive FDA 510(k) clearance?

OneRF Ablation System received FDA 510(k) clearance on 2023-12-06, under 510(k) number K231675.

Who is the listed applicant for OneRF Ablation System?

The FDA 510(k) record lists Neuroone Medical Technologies Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OneRF Ablation System?

The FDA product code for OneRF Ablation System is GXD.

列明Neuroone Medical Technologies Corp.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。

K251243OneRF 三叉神经射频探针 K222404Evo® sEEG 系统 K211367Evo sEEG 系统

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 Corporation K242057COOLIEF* 射频发生器（CRG-BASIC，CRG-BASIC-R，CRG-ADVANCED，CRG-ADVANCED-R）Avanos Medical, Inc.K232632Racz 神经调节射频发生器Epimed International K220122APEX 6Rf Innovations, Inc.K203293Abbott 医疗接地垫，型号 RF-DGP-ISABBOTT MEDICAL K201610IonicRF发生器ABBOTT MEDICAL

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