FDA 510(k) Application Details - K173248

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K173248
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	Bioserenity SAS 47 boulevard de l'Hopital Paris 75013 FR Other 510(k) Applications for this Company
Contact	Quang Tran Other 510(k) Applications for this Contact
Regulation Number	870.2920   More FDA Info for this Regulation Number
Classification Product Code	DXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/2017
Decision Date	08/11/2018
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