SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K072233
Device Name SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS
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 08/10/2007
Decision Date 10/05/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls