NICO BrainPath
K号: K172433 · 2017-09-07
广告
决定日期2017-09-07
产品代码GZT
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
NICO BrainPath is the device name listed in this FDA 510(k) record. The listed applicant is Nico Corporation. It received FDA 510(k) clearance on 2017-09-07 under 510(k) number K172433. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NICO BrainPath?
NICO BrainPath is a medical device that received FDA 510(k) clearance on 2017-09-07. The listed applicant is Nico Corporation. The 510(k) number is K172433.
When did NICO BrainPath receive FDA 510(k) clearance?
NICO BrainPath received FDA 510(k) clearance on 2017-09-07, under 510(k) number K172433.
Who is the listed applicant for NICO BrainPath?
The FDA 510(k) record lists Nico Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NICO BrainPath?
The FDA product code for NICO BrainPath is GZT.
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。
列明Nico Corporation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。
相关器械（代码：GZT）
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。
K252995杜拉盾设备套件SurGenTec, LLCK210615汤普森脑拉钩桌式（TM），汤普森脑拉钩颅骨夹式（SCM）Thompson Surgical Instruments, Inc.K202694Vycor Medical 视频脑部接入系统（“VBAS”）及配备对齐夹的 VBAS（统称为“VBAS 系列产品”）Vycor Medical, Inc.K202072MindsEye 可扩展端口Minnetronix Neuro, Inc.K180610Geister神经和脊柱手术拉钩Geister Medizin Technik GmbHK161680MEDICON脊柱扩张系统Medicon EG
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。
广告