FDA 510(k)

Grass® MR条件/CT杯电极

K号: K242346 · 2024-08-29

决定日期2024-08-29

产品代码GXY

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决定实质等同

器械摘要

Grass® MR Conditional/CT Cup Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Natus Manufacturing Limited. It received FDA 510(k) clearance on 2024-08-29 under 510(k) number K242346. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Grass® MR Conditional/CT Cup Electrodes?

Grass® MR Conditional/CT Cup Electrodes is a medical device that received FDA 510(k) clearance on 2024-08-29. The listed applicant is Natus Manufacturing Limited. The 510(k) number is K242346.

When did Grass® MR Conditional/CT Cup Electrodes receive FDA 510(k) clearance?

Grass® MR Conditional/CT Cup Electrodes received FDA 510(k) clearance on 2024-08-29, under 510(k) number K242346.

Who is the listed applicant for Grass® MR Conditional/CT Cup Electrodes?

The FDA 510(k) record lists Natus Manufacturing Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Grass® MR Conditional/CT Cup Electrodes?

The FDA product code for Grass® MR Conditional/CT Cup Electrodes is GXY.

列明Natus Manufacturing Limited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。

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相关器械（代码：GXY）

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。

K262654Dexus假肢系统（MSL2，MSR2）Zhejiang Qiangnao Technology Co.,Ltd K260578Ambu® NeurolineTM 杯 MRI/CT（型号 72704/21US，72704/23US，72704/25US，72704/27US）Ambu® NeurolineTM 杯 MRI/CT套装（型号 72704/21-1010US，72704/21-1010US，72704/23-1010US，72704/25-1010US，72704/27-1010US）Ambu® NeurolineTM 杯 MRI/CT迷你套装（型号 72704/21-0301US，72704/23-0301US，72704/25-0301US，72704/27-0301US）Ambu A/S K261442Charlotte ACC25 表面电极阵列；Charlotte ACC25 可重复使用表面电极阵列Cadwell Industries, Inc.K261522BioWave BioWrapsBiowave Corporation K253237Elde 医疗电极（T5/ 5cm x 5cm 电极 T10/ 5cm x 10cm 电极）Elde Medikal Sanayi ve Ticaret Anonim Sirketi K254183MR 条件杯电极Technomed Europe

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