The IQool System— 510(k) K162523
Substantially EquivalentBraincool AB
FDA 510(k) clearance K162523 for The IQool System, Substantially Equivalent on 2017-05-03. Applicant: Braincool AB. Device class: 2.
Clearance details
- Applicant
- Braincool AB
- Product code
- Code NZE
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medicon Village, SE
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