FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GEN-X 800/300
K Number: K915339
·
Decision Jan 9, 1992
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
162
Applicant Total
3
Review Days
50
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Basic Information
- Device Name
- GEN-X 800/300
- K Number
- K915339
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Swissray Finatech, Inc.
- Date Received
- November 20, 1991
- Decision Date
- January 9, 1992
- 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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