FDA 510(k) Application Details - K010099

Device Classification Name	Electrode, Pacemaker, Temporary   More FDA Info for this Device
510(K) Number	K010099
Device Name	Electrode, Pacemaker, Temporary
Applicant	ZCV ,INC. 298 FERNWOOD AVE. EDISON, NJ 08837 US Other 510(k) Applications for this Company
Contact	JING ZHANG Other 510(k) Applications for this Contact
Regulation Number	870.3680   More FDA Info for this Regulation Number
Classification Product Code	LDF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/11/2001
Decision Date	02/01/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review