Rapid ASPECTS— 510(k) K200760
Substantially EquivalentIschemaview, Inc.
FDA 510(k) clearance K200760 for Rapid ASPECTS, Substantially Equivalent on 2020-06-26. Applicant: Ischemaview, Inc.. Device class: 2.
Clearance details
- Applicant
- Ischemaview, Inc.
- Product code
- Code POK
- Device class
- Class 2
- Regulation
- 21 CFR 892.2060
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Golden, CO, US
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