FDA 510(k)

NeuroCap (型号 DEC22)

K号: K202913 · 2021-03-05

决定日期2021-03-05

产品代码GXY

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

NeuroCap (Model DEC22) is the device name listed in this FDA 510(k) record. The listed applicant is Memory MD, Inc.. It received FDA 510(k) clearance on 2021-03-05 under 510(k) number K202913. 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 NeuroCap (Model DEC22)?

NeuroCap (Model DEC22) is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Memory MD, Inc.. The 510(k) number is K202913.

When did NeuroCap (Model DEC22) receive FDA 510(k) clearance?

NeuroCap (Model DEC22) received FDA 510(k) clearance on 2021-03-05, under 510(k) number K202913.

Who is the listed applicant for NeuroCap (Model DEC22)?

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

What is the FDA product code for NeuroCap (Model DEC22)?

The FDA product code for NeuroCap (Model DEC22) is GXY.

列明Memory MD, 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。

K172866NeuroCap K173460NeuroEEG

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

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。