FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PORTA RAY MODEL 325
K Number: K864339
·
Decision Dec 15, 1986
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
162
Applicant Total
4
Review Days
41
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Basic Information
- Device Name
- PORTA RAY MODEL 325
- K Number
- K864339
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Porta Ray, Inc.
- Date Received
- November 4, 1986
- Decision Date
- December 15, 1986
- Product Code
- IZO
- 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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | FDA class 1 | Radiology |
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