Rapid LVO— 510(k) K200941
Substantially EquivalentIschemaview, Inc.
FDA 510(k) clearance K200941 for Rapid LVO, Substantially Equivalent on 2020-07-09. 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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