WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES

Device Classification Name

standard polysomnograph with electroencephalograph

510(k) Number K033475
Device Name WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES
Applicant
NIHON KOHDEN AMERICA, INC.
90 icon st.
foothill ranch, 
CA 
92610 -1601

Applicant Contact serrah namini
Correspondent
NIHON KOHDEN AMERICA, INC.
90 icon st.
foothill ranch, 
CA 
92610 -1601

Correspodent Contact serrah namini
Regulation Number 882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received 11/03/2003
Decision Date 01/07/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No