Rapid Obstructive Hydrocephalus, Rapid OH— 510(k) K251533
Substantially EquivalentIschemaview, Inc.
FDA 510(k) clearance K251533 for Rapid Obstructive Hydrocephalus, Rapid OH, Substantially Equivalent on 2025-09-04. Applicant: Ischemaview, Inc.. Device class: 2.
Clearance details
- Applicant
- Ischemaview, Inc.
- Product code
- Code QAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.2080
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Golden, CO, US
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