Clearance Summary
Veenstra Instruments VDC-506 Dose Calibrator received FDA 510(k) clearance under submission number K142325, sponsored by Comecer Netherlands B.V.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2014-09-18.
- Submission: K142325
- Applicant / Sponsor: Comecer Netherlands B.V.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1360
- Decision date: 2014-09-18
Classification & Regulation
This clearance is catalogued under FDA product code KPT and 21 CFR 892.1360, within the Radiology review panel as a Class II device.