FDA 510(k) Application Details - K233580

Device Classification Name	Device, Biofeedback   More FDA Info for this Device
510(K) Number	K233580
Device Name	Device, Biofeedback
Applicant	DeepWell DTx Inc. 5608 17 Ave NW Suite 570 Seattle, WA 98107 US Other 510(k) Applications for this Company
Contact	Jeff Harris Other 510(k) Applications for this Contact
Regulation Number	882.5050   More FDA Info for this Regulation Number
Classification Product Code	HCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/2023
Decision Date	08/01/2024
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