Veenstra Instruments VDC-506 Dose Calibrator
FDA 510(k) K142325 · Comecer Netherlands B.V.
510(k) numberK142325
Submission
- Device name
- Veenstra Instruments VDC-506 Dose Calibrator
- Applicant
- Comecer Netherlands B.V.
Joure, NL - Received
- August 20, 2014
- Decision date
- September 18, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K011493 | Mentor Isoloader Automatic Needle Loading System and Physics Workstation for BrachytherapyKPT · Traditional | Mentor Corp. | 10/01/2002SE |
| K020150 | CRC-15BTKPT · Traditional | Capintec, Inc. | 08/02/2002SE |
Questions and answers
When was Veenstra Instruments VDC-506 Dose Calibrator cleared by the FDA?
Veenstra Instruments VDC-506 Dose Calibrator (K142325) received a 510(k) decision of Substantially Equivalent on September 18, 2014, 29 days after the submission was received.
What is the product code of K142325?
The FDA product code is KPT – Calibrator, Dose, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1360.