FDA 510(k) Application Details - K130288

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K130288
Device Name	Recorder, Magnetic Tape, Medical
Applicant	CARDIAC INSIGHT, INC. 5672 FLAGLER ROAD NORDLAND, WA 98358 US Other 510(k) Applications for this Company
Contact	DEBORAH SHEFFIELD Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	DSH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/2013
Decision Date	05/29/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review