FDA 510(k) Application Details - K960449

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K960449
Device Name	Electrocardiograph
Applicant	BIOSENSOR CORP. 13755 FIRST AVENUE NORTH PLYMOUTH, MN 55441 US Other 510(k) Applications for this Company
Contact	B.STEVEN SPRINGROSE 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	01/30/1996
Decision Date	05/30/1996
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