Clearance Summary
PULSED SELECTRON received FDA 510(k) clearance under submission number K902533, sponsored by Nucletron-Oldelft Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1990-10-12.
- Submission: K902533
- Applicant / Sponsor: Nucletron-Oldelft Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 1990-10-12
Classification & Regulation
This clearance is catalogued under FDA product code JAQ and 21 CFR 892.5700, within the Radiology review panel as a Class II device.