BRAIN COIL, MODEL 9800GE-64— 510(k) K003097
Substantially EquivalentMidwest Rf, LLC
FDA 510(k) clearance K003097 for BRAIN COIL, MODEL 9800GE-64, Substantially Equivalent on 2000-12-28. Applicant: Midwest Rf, LLC. Device class: 2.
Clearance details
- Applicant
- Midwest Rf, 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
- Hartland, WI, US
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