Clearance Summary
OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 received FDA 510(k) clearance under submission number K030737, sponsored by Ctf Systems (2001), Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2003-10-10.
- Submission: K030737
- Applicant / Sponsor: Ctf Systems (2001), Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2003-10-10
Classification & Regulation
This clearance is catalogued under FDA product code OLX and 21 CFR 882.1400, within the Neurology review panel as a Class II device.