OLINDA EXM— 510(k) K163687
Substantially EquivalentHermes Medical Solutions AB
FDA 510(k) clearance K163687 for OLINDA EXM, Substantially Equivalent on 2017-07-19. Applicant: Hermes Medical Solutions AB. Device class: 1.
Clearance details
- Applicant
- Hermes Medical Solutions AB
- Product code
- Code IYX
- Device class
- Class 1
- Regulation
- 21 CFR 892.1100
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
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