Clearance Summary
VPS 2250, CSU2250 & VFU 2250 received FDA 510(k) clearance under submission number K844659, sponsored by Madsen Electronics (Canada) , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1985-02-25.
- Submission: K844659
- Applicant / Sponsor: Madsen Electronics (Canada) , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1890
- Decision date: 1985-02-25
Classification & Regulation
This clearance is catalogued under FDA product code GWE and 21 CFR 882.1890, within the Neurology review panel as a Class II device.