NIKOMED TRACE 1 ECG ELECTRODES


Device Classification Name

electrode, electrocardiograph

510(k) Number K022909
Device Name NIKOMED TRACE 1 ECG ELECTRODES
Original Applicant
NIKOMED U.S.A., INC.
p.o. box 560
stillwater, 
MN 
55082

Original Contact elaine duncan
Regulation Number 870.2360
Classification Product Code
DRX  
Date Received 09/03/2002
Decision Date 01/09/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No