SCP

Computerized Behavioral Therapy Device For Anxiety Disorders

Product code
SCP
Device name
Computerized Behavioral Therapy Device For Anxiety Disorders
Device class
Class 2
21 CFR
21 CFR 882.5801
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1

FDA classification definition

Computerized behavioral therapy device for psychiatric disorders

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-08-30.

NumberDecision dateApplicantDevice nameSummary
K2338722024-08-30Big Health, Inc.DaylightPDF

1 summaries are archived here for direct download.

Official FDA classification page: SCP
Classification and pathway per current FDA publications. Data from openFDA (CC0).