Rapid ASPECTS— 510(k) K200760

Substantially Equivalent

Ischemaview, Inc.

FDA 510(k) clearance K200760 for Rapid ASPECTS, Substantially Equivalent on 2020-06-26. Applicant: Ischemaview, Inc..

Clearance details

Applicant: Ischemaview, Inc.
Product code: Code POK
Advisory panel: Radiology
Date received: 2020-03-24
Decision date: 2020-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

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