FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL
K Number: K071847
·
Decision Jul 23, 2007
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
478
Applicant Total
8
Review Days
18
Basic Information
- Device Name
- MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL
- K Number
- K071847
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
- Date Received
- July 5, 2007
- Decision Date
- July 23, 2007
- Product Code
- MOS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | FDA class 2 | Radiology |
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