1.5T GEM FLEX COIL— 510(k) K113474
Substantially EquivalentNeocoil, LLC
FDA 510(k) clearance K113474 for 1.5T GEM FLEX COIL, Substantially Equivalent on 2012-03-16. Applicant: Neocoil, LLC. Device class: 2.
Clearance details
- Applicant
- Neocoil, 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
- Abbreviated
- Location
- Pewaukee, WI, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.