Clearance Summary
CADWELL FLEX EEG/PSG received FDA 510(k) clearance under submission number K133355, sponsored by Cadwell Industries, 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 2014-01-29.
- Submission: K133355
- Applicant / Sponsor: Cadwell Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2014-01-29
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.