FDA 510(k) Application Details - K183152

Device Classification Name	More FDA Info for this Device
510(K) Number	K183152
Device Name	Phoenix
Applicant	US Bionics, Inc. (DBA suitX) 4512 Hollis Street Emeryville, CA 94608 US Other 510(k) Applications for this Company
Contact	Kelly Mettler Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2018
Decision Date	04/17/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review