FDA 510(k) Application Details - K050443

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K050443
Device Name	Electrode, Electrocardiograph
Applicant	KENTEC MEDICAL, INC. 20492 CRESCENT BAY DR SUITE 106 LAKE FOREST, CA 92630 US Other 510(k) Applications for this Company
Contact	DAVID SHERATON Other 510(k) Applications for this Contact
Regulation Number	870.2360   More FDA Info for this Regulation Number
Classification Product Code	DRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/2005
Decision Date	09/02/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review