FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAGE 7
K Number: K984167
·
Decision Jan 12, 1999
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
9
Applicant Total
169
Review Days
53
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Basic Information
- Device Name
- SAGE 7
- K Number
- K984167
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE Medical Systems
- Date Received
- November 20, 1998
- Decision Date
- January 12, 1999
- Product Code
- LNI
- 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 |
|---|---|---|---|
| LNI | System, Nuclear Magnetic Resonance Spectroscopic | FDA class 2 | Radiology |
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