SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL


Device Classification Name

electrode, electrocardiograph

510(k) Number K024247
Device Name SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
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 12/23/2002
Decision Date 01/16/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No