FDA 510(k), K092573, NIHON KOHDEN QP-160AK EEG TREND PROGRAM

510(K) Number: K092573
Device Name: NIHON KOHDEN QP-160AK EEG TREND PROGRAM
Manufacturer: NIHON KOHDEN AMERICA, INC.
Device Classification Name: amplitude-integrated electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OMA
Date Received: 08/20/2009
Decision Date: 07/09/2010
Regulation Medical Specialty: Neurology

Total pages: 872
Fully redacted pages: 404
Content pages: 468