FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W
K Number: K041557
·
Decision Jun 25, 2004
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
4
Review Days
15
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Basic Information
- Device Name
- MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W
- K Number
- K041557
- 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
- June 10, 2004
- Decision Date
- June 25, 2004
- 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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