FDA 510(k) Application Details - K123217

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K123217
Device Name	Electrocardiograph
Applicant	CARDEA ASSOCIATES INC 137220 220TH PLACE NE WOODINVILLE, WA 98077 US Other 510(k) Applications for this Company
Contact	DAVID M HADLEY 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	10/15/2012
Decision Date	02/05/2013
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	Y
Expedited Review