FDA 510(k) Application Details - K091054

Device Classification Name	Electrocardiograph,Ambulatory(Without Analysis)   More FDA Info for this Device
510(K) Number	K091054
Device Name	Electrocardiograph,Ambulatory(Without Analysis)
Applicant	ET MEDICAL DEVICES SPA 6, VIA DE ZINIS CAVARENO(TN) 38011 IT Other 510(k) Applications for this Company
Contact	LUIGO BUCCHI 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	04/13/2009
Decision Date	07/27/2009
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