FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KODAK MIN-R MEDIUM SCREEN
K Number: K873167
·
Decision Aug 27, 1987
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
34
Applicant Total
238
Review Days
16
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Basic Information
- Device Name
- KODAK MIN-R MEDIUM SCREEN
- K Number
- K873167
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1960
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Eastman Kodak Company
- Date Received
- August 11, 1987
- Decision Date
- August 27, 1987
- 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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| K042159 | KODAK COLOR MEDICAL IMAGER 1000 | Sep 24, 2004 | Substantially Equivalent |
| K042158 | KODAK MEDICAL IMAGER 300 | Sep 24, 2004 | Substantially Equivalent |
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