FDA 510(k) Application Details - K211822

Device Classification Name	Transmitters And Receivers, Physiological Signal, Radiofrequency   More FDA Info for this Device
510(K) Number	K211822
Device Name	Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant	Elastic Care Incorporated 95 Apple Creek Blvd. Markham L3R 1C7 CA Other 510(k) Applications for this Company
Contact	Ashok Kalle 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	06/14/2021
Decision Date	02/03/2022
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	Y
Expedited Review