Clearance Summary
REMVIEW SLEEP RECORDER, MODEL 320 received FDA 510(k) clearance under submission number K003499, sponsored by Respironics, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-02-09.
- Submission: K003499
- Applicant / Sponsor: Respironics, Inc.
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 2001-02-09
Classification & Regulation
This clearance is catalogued under FDA product code LEL and 21 CFR 882.5050, within the Neurology review panel as a Class II device.