Clearance Summary
OLYMPIC BRAINZ MONITOR MODEL OBM70001 received FDA 510(k) clearance under submission number K093949, sponsored by Natus Medical, 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 2010-06-16.
- Submission: K093949
- Applicant / Sponsor: Natus Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2010-06-16
Classification & Regulation
This clearance is catalogued under FDA product code OMA and 21 CFR 882.1400, within the Neurology review panel as a Class II device.