PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION


Device Classification Name

monitor, physiological, patient(with arrhythmia detection or alarms)

510(k) Number K073550
Device Name PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION
Applicant
NIHON KOHDEN AMERICA, INC.
90 icon st.
foothill ranch, 
CA 
92610 -1601

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

Correspodent Contact jack coggan
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 12/18/2007
Decision Date 03/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No