FDA 510(k) Application Details - K991293

Device Classification Name	Generator, Pulse, Pacemaker, External Programmable   More FDA Info for this Device
510(K) Number	K991293
Device Name	Generator, Pulse, Pacemaker, External Programmable
Applicant	FISCHER MEDICAL TECHNOLOGIES, INC. 12300 NORTH GRANT DENVER, CO 80241 US Other 510(k) Applications for this Company
Contact	RONALD SHORES Other 510(k) Applications for this Contact
Regulation Number	870.1750   More FDA Info for this Regulation Number
Classification Product Code	JOQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/1999
Decision Date	05/05/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review