FDA 510(k) Application Details - K133753

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K133753
Device Name	Detector And Alarm, Arrhythmia
Applicant	INFOBIONIC, INC. 600 SUFFOLK STREET P.O. BOX 9719 LOWELL, MA 01853 US Other 510(k) Applications for this Company
Contact	CARRIE NEUBERGER Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	DSI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2013
Decision Date	09/19/2014
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