ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M


Device Classification Name

electrocardiograph

510(k) Number K072217
Device Name ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M
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 870.2340
Classification Product Code
DPS  
Date Received 08/09/2007
Decision Date 08/30/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No