FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAREX & OPTEX X-RAY SCREENS
K Number: K902039
·
Decision Jul 27, 1990
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
34
Applicant Total
4
Review Days
84
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Basic Information
- Device Name
- RAREX & OPTEX X-RAY SCREENS
- K Number
- K902039
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1960
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Mci Optonix, Inc.
- Date Received
- May 4, 1990
- Decision Date
- July 27, 1990
- Product Code
- EAM
- 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 |
|---|---|---|---|
| EAM | Screen, Intensifying, Radiographic | FDA class 1 | Radiology |
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