FDA 510(k) Application Details - K191620

Device Classification Name	Transmitters And Receivers, Physiological Signal, Radiofrequency   More FDA Info for this Device
510(K) Number	K191620
Device Name	Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant	Vitls Inc. TMC Innovation Institute, Suite X, 2450 Holcombe Blvd. Houston, TX 77021 US Other 510(k) Applications for this Company
Contact	Werner Vorster 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	06/18/2019
Decision Date	06/01/2020
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