FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AFGA VIDEO IMAGER, VARIOUS MODELS
K Number: K903238
·
Decision Nov 2, 1990
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
120
Applicant Total
4
Review Days
107
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Basic Information
- Device Name
- AFGA VIDEO IMAGER, VARIOUS MODELS
- K Number
- K903238
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2040
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Enhanced Imaging Technologies, Inc.
- Date Received
- July 18, 1990
- Decision Date
- November 2, 1990
- Product Code
- LMC
- 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 |
|---|---|---|---|
| LMC | Camera, Multi Format, Radiological | FDA class 2 | Radiology |
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