SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE


Device Classification Name

electrode, electrocardiograph

510(k) Number K080106
Device Name SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE
Applicant
LEONHARD LANG GMBH
p.o. box 560
stillwater, 
MN 
55082 -0560

Applicant Contact elaine duncan
Correspondent
LEONHARD LANG GMBH
p.o. box 560
stillwater, 
MN 
55082 -0560

Correspodent Contact elaine duncan
Regulation Number 870.2360
Classification Product Code
DRX  
Date Received 01/15/2008
Decision Date 02/01/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No