Ortho Device, ADAPTIX 3D Orthopedic Imaging System— 510(k) K221949
Substantially EquivalentPausch Medical GmbH
FDA 510(k) clearance K221949 for Ortho Device, ADAPTIX 3D Orthopedic Imaging System, Substantially Equivalent on 2023-01-26. Applicant: Pausch Medical GmbH. Device class: 2.
Clearance details
- Applicant
- Pausch Medical GmbH
- Product code
- Code IZF
- Device class
- Class 2
- Regulation
- 21 CFR 892.1740
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Erlangen, DE
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