FDA 510(k) Application Details - DEN220083

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220083
Device Name	Stanza
Applicant	Swing Therapeutics, Inc. 548 Market Street #63989 San Francisco, CA 94104 US Other 510(k) Applications for this Company
Contact	Michael Rosenbluth Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2022
Decision Date	05/09/2023
Decision	DENG -
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review