FDA 510(k) Application Details - K223073

Device Classification Name	Transmitters And Receivers, Physiological Signal, Radiofrequency   More FDA Info for this Device
510(K) Number	K223073
Device Name	Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant	Alio, Inc. 10901 W. 120th Ave, Suite 380 Broomfield, CO 80021 US Other 510(k) Applications for this Company
Contact	Kimberly Snyder 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	09/30/2022
Decision Date	03/17/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review