Clearance Summary
PSG-1100 SLEEP DIAGNOSTIC SYSTEM received FDA 510(k) clearance under submission number K120888, sponsored by Nihon Kohden 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 2012-11-09.
- Submission: K120888
- Applicant / Sponsor: Nihon Kohden Corp.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2012-11-09
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.