Clearance Summary
OLYMPIC CFM 6000 received FDA 510(k) clearance under submission number K031149, sponsored by Olympic Medical Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2003-05-14.
- Submission: K031149
- Applicant / Sponsor: Olympic Medical Corp.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2003-05-14
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.