FDA 510(k) Application Details - K001317

Device Classification Name	Electrocardiograph,Ambulatory(Without Analysis)   More FDA Info for this Device
510(K) Number	K001317
Device Name	Electrocardiograph,Ambulatory(Without Analysis)
Applicant	DEL MAR MEDICAL SYSTEMS, LLC. 1621 ALTON PKWY. IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	ED CRESPIN Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2000
Decision Date	07/21/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review