FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VELO ACE
K Number: K940540
·
Decision Jul 18, 1994
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
82
Applicant Total
2
Review Days
161
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Basic Information
- Device Name
- VELO ACE
- K Number
- K940540
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Emix U.S.A., Inc.
- Date Received
- February 7, 1994
- Decision Date
- July 18, 1994
- Product Code
- IXW
- 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 |
|---|---|---|---|
| IXW | Processor, Radiographic-Film, Automatic | FDA class 2 | Radiology |
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Other Clearances by Emix U.S.A., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951734 | LUMIX 70B | Jul 20, 1995 | Substantially Equivalent |