FDA 510(k) Application Details - K983232

Device Classification Name	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)   More FDA Info for this Device
510(K) Number	K983232
Device Name	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Applicant	TZ MEDICAL, INC. 15858 S.W. UPPER BOONES FERRY RD. LAKE OSWEGO, OR 97035 US Other 510(k) Applications for this Company
Contact	BYRON G ZAHLER Other 510(k) Applications for this Contact
Regulation Number	870.5550   More FDA Info for this Regulation Number
Classification Product Code	DRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/14/1998
Decision Date	09/15/1999
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