FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THERAVIEW
K Number: K960510
·
Decision Apr 22, 1996
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
14
Review Days
77
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Basic Information
- Device Name
- THERAVIEW
- K Number
- K960510
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Infimed, Inc.
- Date Received
- February 5, 1996
- Decision Date
- April 22, 1996
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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