FDA 510(k) Application Details - K171406

Device Classification Name	Transmitters And Receivers, Physiological Signal, Radiofrequency   More FDA Info for this Device
510(K) Number	K171406
Device Name	Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant	United Health Group Inc. 1100 King Street, Buliding 6, Suite 300 Rye Brook, NY 10573 US Other 510(k) Applications for this Company
Contact	Donald J. Matthews 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	05/12/2017
Decision Date	08/18/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review