FDA 510(k) Application Details - K201873

Device Classification Name	More FDA Info for this Device
510(K) Number	K201873
Device Name	Sparrow Therapy System
Applicant	Spark Biomedical, Inc. 18208 Preston Road, Suite D9-531 Dallas, TX 75252 US Other 510(k) Applications for this Company
Contact	Daniel Powell Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/2020
Decision Date	01/02/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review