WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES


Device Classification Name

electrocardiograph

510(k) Number K002473
Device Name WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
Original Applicant
NIHON KOHDEN AMERICA, INC.
90 icon st.
foothill ranch, 
CA 
92610 -1601

Original Contact bonnie bishop
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 08/11/2000
Decision Date 11/08/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No