FDA 510(k) Application Details - K172329

Device Classification Name	Transmitters And Receivers, Physiological Signal, Radiofrequency   More FDA Info for this Device
510(K) Number	K172329
Device Name	Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant	Isansys Lifecare Ltd 8C Park Square Milton Park, Abingdon Oxford OX14 4RR GB Other 510(k) Applications for this Company
Contact	Julian Jones 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	08/02/2017
Decision Date	04/23/2018
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