SCP — Computerized Behavioral Therapy Device For Anxiety Disorders Class II

FDA Device Classification

FDA product code SCP covers "Computerized Behavioral Therapy Device For Anxiety Disorders", a Class II medical device regulated under 21 CFR 882.5801. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
SCP
Device Class
Class II
Regulation Number
882.5801
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Definition

Computerized behavioral therapy device for psychiatric disorders

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233872big healthDaylightAugust 30, 2024