Clearance Summary
CEREBRAL STATE MONITOR - CSM received FDA 510(k) clearance under submission number K042315, sponsored by Danmeter A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2005-01-21.
- Submission: K042315
- Applicant / Sponsor: Danmeter A/S
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2005-01-21
Classification & Regulation
This clearance is catalogued under FDA product code OLW and 21 CFR 882.1400, within the Neurology review panel as a Class II device.