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FDA 510(k)

Coolief射频发生器（CRG）系统

K号: K192491 · 2020-02-21

申请人Avanos Medical, Inc.
决定日期2020-02-21
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

Coolief Radiofrequency Generator (CRG) System is the device name listed in this FDA 510(k) record. The listed applicant is Avanos Medical, Inc.. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K192491. 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 Coolief Radiofrequency Generator (CRG) System?

Coolief Radiofrequency Generator (CRG) System is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Avanos Medical, Inc.. The 510(k) number is K192491.

When did Coolief Radiofrequency Generator (CRG) System receive FDA 510(k) clearance?

Coolief Radiofrequency Generator (CRG) System received FDA 510(k) clearance on 2020-02-21, under 510(k) number K192491.

Who is the listed applicant for Coolief Radiofrequency Generator (CRG) System?

The FDA 510(k) record lists Avanos Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Coolief Radiofrequency Generator (CRG) System?

The FDA product code for Coolief Radiofrequency Generator (CRG) System 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Avanos Medical, Inc.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。

K243572Game Ready 系统（550500-04）；Game Ready 控制单元（550550-04）；Game Ready 全腿靴套 - 中号（590923-04）；Game Ready 全腿靴套 - 大号（590922-04）；Game Ready C-T 脊柱套（590502-04）；Game Ready 半腿靴（590906-04）；Game Ready 背部套（590500-04）；Game Ready 手/腕套（590811-04）；Game Ready 弯曲肘部套（590903-04）；Game Ready 直立肘部套（590200-04）；Game Ready 肩部套，中号，右侧（590422-04）；Game Ready 肩部套，LaK241185CORGRIP* SR NG/NI 管道固定系统K242057COOLIEF* 射频发生器（CRG-BASIC，CRG-BASIC-R，CRG-ADVANCED，CRG-ADVANCED-R）K240965CORTRAK* 2 肠内营养通路系统（20-0950）K220588Avanos* CORTRAK* 2肠内通路系统（EAS）K203066COOLIEF 冷射频套件高级版

查看所有 8 个设备 →

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.K232632Racz 神经调节射频发生器Epimed InternationalK231675OneRF Ablation SystemNeuroone Medical Technologies Corp.K220122APEX 6Rf Innovations, Inc.K203293Abbott 医疗接地垫，型号 RF-DGP-ISABBOTT MEDICAL

官方来源

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