FDA 510(k) Application Details - K002497

Device Classification Name	Analyzer, Pacemaker Generator Function   More FDA Info for this Device
510(K) Number	K002497
Device Name	Analyzer, Pacemaker Generator Function
Applicant	PACE MEDICAL 391 TOTTEN POND RD. WALTHAM, MA 02451 US Other 510(k) Applications for this Company
Contact	ROBERT C MACE Other 510(k) Applications for this Contact
Regulation Number	870.3630   More FDA Info for this Regulation Number
Classification Product Code	DTC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2000
Decision Date	10/10/2000
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