PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL— 510(k) K140998
Substantially EquivalentQuality Electrodynamics, LLC
FDA 510(k) clearance K140998 for PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL, Substantially Equivalent on 2014-07-11. Applicant: Quality Electrodynamics, LLC. Device class: 2.
Clearance details
- Applicant
- Quality Electrodynamics, 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
- Traditional
- Location
- Mayfield Village, OH, US
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