FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
Veenstra Instruments VDC-506 Dose Calibrator
K Number: K142325
·
Decision Sep 18, 2014
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
31
Applicant Total
1
Review Days
29
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Basic Information
- Device Name
- Veenstra Instruments VDC-506 Dose Calibrator
- K Number
- K142325
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1360
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Comecer Netherlands B.V.
- Date Received
- August 20, 2014
- Decision Date
- September 18, 2014
- 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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