FDA 510(k) Application Details - K101024

Device Classification Name	Electrocardiograph,Ambulatory(Without Analysis)   More FDA Info for this Device
510(K) Number	K101024
Device Name	Electrocardiograph,Ambulatory(Without Analysis)
Applicant	SUZUKEN CO., LTD. 1201 RICHARDSON SUITE 280 RICHARDSON, TX 75080 US Other 510(k) Applications for this Company
Contact	LINDA MORGAN 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	04/13/2010
Decision Date	01/06/2011
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