FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR
K Number: K951764
·
Decision Oct 7, 1995
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
8
Review Days
173
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Basic Information
- Device Name
- UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR
- K Number
- K951764
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ptw-New York Corp.
- Date Received
- April 17, 1995
- Decision Date
- October 7, 1995
- 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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