FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAXIMAX - 4
K Number: K841649
·
Decision Jun 5, 1984
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
9
Applicant Total
20
Review Days
46
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Basic Information
- Device Name
- MAXIMAX - 4
- K Number
- K841649
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1870
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Cgr Medical Corp.
- Date Received
- April 20, 1984
- Decision Date
- June 5, 1984
- Product Code
- IZP
- 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 |
|---|---|---|---|
| IZP | Programmer, Changer, Film/Cassette, Radiographic | FDA class 2 | Radiology |
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