FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AP-6CR CINERADIOGRAPHIC FILM PROCESSOR
K Number: K915365
·
Decision Aug 27, 1992
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
3
Review Days
274
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Basic Information
- Device Name
- AP-6CR CINERADIOGRAPHIC FILM PROCESSOR
- K Number
- K915365
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- The Allen Products Co.
- Date Received
- November 27, 1991
- Decision Date
- August 27, 1992
- 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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