FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROFILE 7000 C-SPINE COIL
K Number: K943440
·
Decision Oct 6, 1995
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
4
Review Days
445
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Basic Information
- Device Name
- PROFILE 7000 C-SPINE COIL
- K Number
- K943440
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Us Asia Instruments, Inc.
- Date Received
- July 18, 1994
- Decision Date
- October 6, 1995
- Product Code
- LNH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
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