510(k) Premarket Notification

• Device Classification Name: full-montage standard electroencephalograph
• 510(K) Number: K120888
• Model: PSG-1100
• Device Name: PSG-1100 SLEEP DIAGNOSTIC SYSTEM
• Applicant: NIHON KOHDEN CORP.; 90 icon street; foothill ranch, CA 92610
• Contact: steve geerdes
• Regulation Number: 882.1400
• Classification Product Code: GWQ
• Subsequent Product Code: OLV
• Date Received: 03/23/2012
• Decision Date: 11/09/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Neurology
• Review Advisory Committee: Neurology
• summary: summary
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No