FDA 510(k) Application Details - K082124

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K082124
Device Name	Electrocardiograph
Applicant	ET MEDICAL DEVICES SPA VIA DE ZINIS 6 CAVARENO 38011 IT Other 510(k) Applications for this Company
Contact	LUIGI BUCCHI Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/2008
Decision Date	02/19/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review