FDA 510(k) Application Details - K130207

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K130207
Device Name	Electrocardiograph
Applicant	SPACELABS HEALTHCARE LTD. PO BOX 3018 NEDERLAND, CO 80466 US Other 510(k) Applications for this Company
Contact	THOMAS KROENKE 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	01/28/2013
Decision Date	07/23/2013
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	N
Expedited Review