FDA 510(k) Application Details - K202940

Device Classification Name	More FDA Info for this Device
510(K) Number	K202940
Device Name	First Relief v1
Applicant	DyAnsys, Inc 300, North Bayshore Boulevard San Mateo, CA 94401 US Other 510(k) Applications for this Company
Contact	Srini Nageshwar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QHH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2020
Decision Date	12/29/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review