Clearance Summary
DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM received FDA 510(k) clearance under submission number K944833, sponsored by New England Medical Monitoring Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1995-05-04.
- Submission: K944833
- Applicant / Sponsor: New England Medical Monitoring Co.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 1995-05-04
Classification & Regulation
This clearance is catalogued under FDA product code OMB and 21 CFR 882.1400, within the Neurology review panel as a Class II device.