FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FILM PROCESSOR, AUTOMATIC
K Number: K770783
·
Decision May 10, 1977
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
8
Applicant Total
254
Review Days
8
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Basic Information
- Device Name
- FILM PROCESSOR, AUTOMATIC
- K Number
- K770783
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- General Electric Co.
- Date Received
- May 2, 1977
- Decision Date
- May 10, 1977
- Product Code
- EGY
- 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 |
|---|---|---|---|
| EGY | Processor, Radiographic-Film, Automatic, Dental | FDA class 2 | Radiology |
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