FDA 510(k) Application Details - K093339

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K093339
Device Name	Electrocardiograph
Applicant	MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. MILWAUKEE, WI 53224 US Other 510(k) Applications for this Company
Contact	CHARLES MORREALE 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	10/26/2009
Decision Date	02/19/2010
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