FDA 510(k) Application Details - K982803

Device Classification Name	More FDA Info for this Device
510(K) Number	K982803
Device Name	HEARTLINK, MODEL II
Applicant	CARDIAC TELECOM CORP. 503 BRADDOCK AVE. 2ND FLOOR TURTLE CREEK, PA 15145-2066 US Other 510(k) Applications for this Company
Contact	LEE G DENEAULT Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/1998
Decision Date	11/13/1998
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