Hybrid3D— 510(k) K171719
Substantially EquivalentHermes Medical Solutions AB
FDA 510(k) clearance K171719 for Hybrid3D, Substantially Equivalent on 2017-11-21. Applicant: Hermes Medical Solutions AB. Device class: 2.
Clearance details
- Applicant
- Hermes Medical Solutions AB
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
Recent devices under product code KPS
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