Clearance Summary
SENSORMEDICS 4000 SERIES SLEEP SYSTEM received FDA 510(k) clearance under submission number K915856, sponsored by Sensor Medics 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 1992-10-26.
- Submission: K915856
- Applicant / Sponsor: Sensor Medics Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 1992-10-26
Classification & Regulation
This clearance is catalogued under FDA product code OLZ and 21 CFR 882.1400, within the Neurology review panel as a Class II device.