Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

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
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

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).