ORTHOSONIX ENERGEX— 510(k) K013094
Substantially EquivalentOrthosonix, Inc.
FDA 510(k) clearance K013094 for ORTHOSONIX ENERGEX, Substantially Equivalent on 2001-12-14. Applicant: Orthosonix, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthosonix, Inc.
- Product code
- Code NHH
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Recent devices under product code NHH
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