FDA 510(k) Application Details - K232833

Device Classification Name	More FDA Info for this Device
510(K) Number	K232833
Device Name	HALO AP Dx
Applicant	Indica Labs, Inc. 8700 Education Place NW Building B Albuquerque, NM 87114 US Other 510(k) Applications for this Company
Contact	Michele Fredrickson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2023
Decision Date	05/07/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review