BoneView— 510(k) K212365
Substantially EquivalentGleamer
FDA 510(k) clearance K212365 for BoneView, Substantially Equivalent on 2022-03-01. Applicant: Gleamer. Device class: 2.
Clearance details
- Applicant
- Gleamer
- Product code
- Code QBS
- Device class
- Class 2
- Regulation
- 21 CFR 892.2090
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saint Mandé, FR
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