FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERIFLEX
K Number: K854410
·
Decision Feb 12, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
3
Review Days
103
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Basic Information
- Device Name
- VERIFLEX
- K Number
- K854410
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Old Delft Corp. of America
- Date Received
- November 1, 1985
- Decision Date
- February 12, 1986
- Product Code
- KPZ
- 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 |
|---|---|---|---|
| KPZ | Generator, High Voltage, X-Ray, Therapeutic | FDA class 2 | Radiology |
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