Planmed Verity— 510(k) K180918
Substantially EquivalentPlanmed OY
FDA 510(k) clearance K180918 for Planmed Verity, Substantially Equivalent on 2018-11-30. Applicant: Planmed OY. Device class: 2.
Clearance details
- Applicant
- Planmed OY
- Product code
- Code OAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Helsinki, FI
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