3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000— 510(k) K061170
Substantially EquivalentResonance Innovations, LLC
FDA 510(k) clearance K061170 for 3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000, Substantially Equivalent on 2006-05-25. Applicant: Resonance Innovations, LLC. Device class: 2.
Clearance details
- Applicant
- Resonance Innovations, LLC
- Product code
- Code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Omaha, NE, US
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More clearances from Resonance Innovations, LLC
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