SKINTACT ECG ELECTRODE


Device Classification Name

electrode, electrocardiograph

510(k) Number K023503
Device Name SKINTACT ECG ELECTRODE
Original Applicant
LEONHARD LANG GMBH
p.o. box 560
stillwater, 
MN 
55082 -0560

Original Contact elaine duncan
Regulation Number 870.2360
Classification Product Code
DRX  
Date Received 10/18/2002
Decision Date 11/14/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No