FDA 510(k)

Rapid 阻塞性脑积水，Rapid OH

K号: K251533 · 2025-09-04

决定日期2025-09-04

产品代码QAS

咨询委员会RA

决定实质等同

器械摘要

Rapid Obstructive Hydrocephalus, Rapid OH is the device name listed in this FDA 510(k) record. The listed applicant is Ischemaview, Inc.. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K251533. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Rapid Obstructive Hydrocephalus, Rapid OH?

Rapid Obstructive Hydrocephalus, Rapid OH is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Ischemaview, Inc.. The 510(k) number is K251533.

When did Rapid Obstructive Hydrocephalus, Rapid OH receive FDA 510(k) clearance?

Rapid Obstructive Hydrocephalus, Rapid OH received FDA 510(k) clearance on 2025-09-04, under 510(k) number K251533.

Who is the listed applicant for Rapid Obstructive Hydrocephalus, Rapid OH?

FDA 510(k)记录中列出Ischemaview，Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Rapid Obstructive Hydrocephalus, Rapid OH?

The FDA product code for Rapid Obstructive Hydrocephalus, Rapid OH is QAS.

列明Ischemaview, 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。

K261368快速平台（R6.7）K251987Rapid 主动脉测量 K252526Rapid DeltaFuse K243378Rapid MLS K243350Rapid Neuro3D K233582Rapid

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官方来源

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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。