Clearance Summary
XYZ SYSTEM received FDA 510(k) clearance under submission number K983550, sponsored by Bio-Monitoring International Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1999-01-07.
- Submission: K983550
- Applicant / Sponsor: Bio-Monitoring International Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 1999-01-07
Classification & Regulation
This clearance is catalogued under FDA product code HCC and 21 CFR 882.5050, within the Neurology review panel as a Class II device.