FDA 510(k) Application Details - K024323

Device Classification Name	Electrocardiograph, Ambulatory, With Analysis Algorithm   More FDA Info for this Device
510(K) Number	K024323
Device Name	Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant	BIOMEDICAL SYSTEMS CORP. 2464 WEST PORT PLAZA DR. ST. LOUIS, MO 63146 US Other 510(k) Applications for this Company
Contact	K. MICHAEL KROEHNKE Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MLO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2002
Decision Date	06/30/2003
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