Clearance Summary
SACS EEG WORKSTATION A7 received FDA 510(k) clearance under submission number K071109, sponsored by Sacs Medical AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2007-06-07.
- Submission: K071109
- Applicant / Sponsor: Sacs Medical AB
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2007-06-07
Classification & Regulation
This clearance is catalogued under FDA product code GWQ and 21 CFR 882.1400, within the Neurology review panel as a Class II device.