Clearance Summary
BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER received FDA 510(k) clearance under submission number K864928, 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 1987-03-31.
- Submission: K864928
- Applicant / Sponsor: Bio-Scan, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 1987-03-31
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.