FDA 510(k) Application Details - K124000

Device Classification Name	Transmitters And Receivers, Physiological Signal, Radiofrequency   More FDA Info for this Device
510(K) Number	K124000
Device Name	Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant	MEDAPPS INC., DBA ALERE CONNECT 8767 E. VIA DE VENTURA, STE 300 SCOTTSDALE, AZ 85258 US Other 510(k) Applications for this Company
Contact	KENT DICKS Other 510(k) Applications for this Contact
Regulation Number	870.2910   More FDA Info for this Regulation Number
Classification Product Code	DRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2012
Decision Date	07/30/2013
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