FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DELTAMANAGER
K Number: K933321
·
Decision Nov 3, 1993
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
459
Applicant Total
3
Review Days
110
Basic Information
- Device Name
- DELTAMANAGER
- K Number
- K933321
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDIMAGE, INC.
- Date Received
- July 16, 1993
- Decision Date
- November 3, 1993
- Product Code
- KPS
- 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 |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | FDA class 2 | Radiology |
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