BRAIN COIL, MODEL 9900GE-64— 510(k) K031536
Substantially EquivalentClinical MR Solutions, LLC
FDA 510(k) clearance K031536 for BRAIN COIL, MODEL 9900GE-64, Substantially Equivalent on 2003-07-18. Applicant: Clinical MR Solutions, LLC. Device class: 2.
Clearance details
- Applicant
- Clinical MR Solutions, 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
- Brookfield, WI, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.