SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K081371
Device Name SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL
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 870.5310
Classification Product Code
MKJ  
Date Received 05/15/2008
Decision Date 09/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls