510(k) K233872

Daylight by Big Health, Inc. — Product Code SCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2024
Date Received
December 7, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computerized Behavioral Therapy Device For Anxiety Disorders
Device Class
Class II
Regulation Number
882.5801
Review Panel
NE
Submission Type

Computerized behavioral therapy device for psychiatric disorders