Rapid Obstructive Hydrocephalus, Rapid OH— 510(k) K251533

Substantially Equivalent

Ischemaview, Inc.

FDA 510(k) clearance K251533 for Rapid Obstructive Hydrocephalus, Rapid OH, Substantially Equivalent on 2025-09-04. Applicant: Ischemaview, Inc..

Clearance details

Applicant: Ischemaview, Inc.
Product code: Code QAS
Advisory panel: Radiology
Date received: 2025-05-19
Decision date: 2025-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

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