FDA 510(k) Application Details - K961798

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K961798
Device Name	Electrocardiograph
Applicant	MACQUARIE MEDICAL SYSTEMS 3407 BAY AVE. CHICO, CA 95973 US Other 510(k) Applications for this Company
Contact	FRANK FERGUSON Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/1996
Decision Date	08/05/1998
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