FDA 510(k) Application Details - K003707

Device Classification Name	Electrocardiograph,Ambulatory(Without Analysis)   More FDA Info for this Device
510(K) Number	K003707
Device Name	Electrocardiograph,Ambulatory(Without Analysis)
Applicant	CARDIONET 6199 CORNERSTONE CT. EAST # 106 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	DONALD CANAL 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	12/01/2000
Decision Date	05/16/2001
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