FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165
K Number: K030066
·
Decision Aug 29, 2003
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
31
Applicant Total
1
Review Days
234
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Basic Information
- Device Name
- CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165
- K Number
- K030066
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1360
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nuclear Associates
- Date Received
- January 7, 2003
- Decision Date
- August 29, 2003
- Product Code
- KPT
- 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 |
|---|---|---|---|
| KPT | Calibrator, Dose, Radionuclide | FDA class 2 | Radiology |
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