FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAXICAMERA II
K Number: K770343
·
Decision Feb 28, 1977
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
254
Review Days
10
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Basic Information
- Device Name
- MAXICAMERA II
- K Number
- K770343
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1100
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- General Electric Co.
- Date Received
- February 18, 1977
- Decision Date
- February 28, 1977
- Product Code
- IYX
- 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 |
|---|---|---|---|
| IYX | Camera, Scintillation (Gamma) | FDA class 1 | Radiology |
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