3.0T GEM RT Open Array— 510(k) K143389
Substantially EquivalentGe Healthcare Coils (Usa Instruments, Inc.)
FDA 510(k) clearance K143389 for 3.0T GEM RT Open Array, Substantially Equivalent on 2015-03-06. Applicant: Ge Healthcare Coils (Usa Instruments, Inc.). Device class: 2.
Clearance details
- Applicant
- Ge Healthcare Coils (Usa Instruments, Inc.)
- 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
- Aurora, OH, US
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More clearances from Ge Healthcare Coils (Usa Instruments, Inc.)
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