FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CINE RADIOGRAPHIC FILM PROCESSOR M-45CR
K Number: K850421
·
Decision Mar 22, 1985
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
3
Review Days
46
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Basic Information
- Device Name
- CINE RADIOGRAPHIC FILM PROCESSOR M-45CR
- K Number
- K850421
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- The Allen Products Co.
- Date Received
- February 4, 1985
- Decision Date
- March 22, 1985
- Product Code
- IXX
- 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 |
|---|---|---|---|
| IXX | Processor, Cine Film | FDA class 2 | Radiology |
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