FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLUOROSCOPIC BRIGHTNESS STABALIZER/FBS MODEL 9205A
K Number: K926064
·
Decision Apr 27, 1993
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
2
Review Days
147
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Basic Information
- Device Name
- FLUOROSCOPIC BRIGHTNESS STABALIZER/FBS MODEL 9205A
- K Number
- K926064
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scientific Technology , Ltd.
- Date Received
- December 1, 1992
- Decision Date
- April 27, 1993
- Product Code
- JAA
- 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
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Other Clearances by Scientific Technology , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K902848 | FASTRECON 88 PERIFERAL | Aug 1, 1990 | Substantially Equivalent |