FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASPECT DIGITAL FORMATTER
K Number: K954149
·
Decision Nov 13, 1995
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
120
Applicant Total
3
Review Days
69
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Basic Information
- Device Name
- ASPECT DIGITAL FORMATTER
- K Number
- K954149
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2040
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aspect Electronics, Inc.
- Date Received
- September 5, 1995
- Decision Date
- November 13, 1995
- Product Code
- LMC
- 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 |
|---|---|---|---|
| LMC | Camera, Multi Format, Radiological | FDA class 2 | Radiology |
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