Clearance Summary
Q.P. PREAMPLIFIER SYS received FDA 510(k) clearance under submission number K841683, sponsored by Bio-Scan, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1984-06-07.
- Submission: K841683
- Applicant / Sponsor: Bio-Scan, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 1984-06-07
Classification & Regulation
This clearance is catalogued under FDA product code GWQ and 21 CFR 882.1400, within the Neurology review panel as a Class II device.