PSG INPUT BOX, MODEL JE-912AK


Device Classification Name

standard polysomnograph with electroencephalograph

510(k) Number K022121
Device Name PSG INPUT BOX, MODEL JE-912AK
Original Applicant
NIHON KOHDEN AMERICA, INC.
90 icon st.
foothill ranch, 
CA 
92610 -1601

Original Contact serrah namini
Regulation Number 882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received 07/01/2002
Decision Date 07/29/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No