FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
X-RAY GENERATING SYSTEM, TF 800
K Number: K881387
·
Decision Jul 8, 1988
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
162
Applicant Total
3
Review Days
98
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Basic Information
- Device Name
- X-RAY GENERATING SYSTEM, TF 800
- K Number
- K881387
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Absolute X-Ray Corp.
- Date Received
- April 1, 1988
- Decision Date
- July 8, 1988
- 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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