FDA 510(k) Application Details - K181248

Device Classification Name	Transmitters And Receivers, Physiological Signal, Radiofrequency   More FDA Info for this Device
510(K) Number	K181248
Device Name	Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant	Comarch Healthcare SA al. Jana Pawla II 39a, Krakow 31-864 PL Other 510(k) Applications for this Company
Contact	Irmina Serafin 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	05/10/2018
Decision Date	10/22/2018
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