SKINTACT


Device Classification Name

electrode, electrocardiograph

510(k) Number K023920
Device Name SKINTACT
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 11/25/2002
Decision Date 01/16/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No