FDA 510(k) Application Details - K211365

Device Classification Name	Transmitters And Receivers, Physiological Signal, Radiofrequency   More FDA Info for this Device
510(K) Number	K211365
Device Name	Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant	Graftworx, Inc. dba Alio 544B Bryant Street San Francisco, CA 94107 US Other 510(k) Applications for this Company
Contact	David Kuraguntla 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	05/04/2021
Decision Date	03/24/2022
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	N
Expedited Review