FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MOSFET AUTOSENSE, MODEL TN-RD-60
K Number: K013279
·
Decision Oct 18, 2001
Classifications
1
FEI Numbers
123
Registration Numbers
124
Same Product Code
717
Applicant Total
4
Review Days
16
Basic Information
- Device Name
- MOSFET AUTOSENSE, MODEL TN-RD-60
- K Number
- K013279
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- THOMSON & NIELSEN ELECTRONICS, LTD.
- Date Received
- October 2, 2001
- Decision Date
- October 18, 2001
- 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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