FDA 510(k) Application Details - K053011

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K053011
Device Name	Electrode, Electrocardiograph
Applicant	BIO PROTECH, INC. 1676 VILLAGE GREEN SUITE A CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	E.J. Smith 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	10/26/2005
Decision Date	12/14/2005
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